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AUTHENTICATED , 
US. GOVERNMENT 
INFORMATION ^ 


FEDERAL OVERSIGHT OF HIGH-CONTAINMENT 
BIOLABORATORIES 


HEARING 

BEFORE THE 

SUBCOMMITTEE ON OA^RSIGHT AND 
im^STIGATIONS 

OF THE 

COMMITTEE ON ENERGY AND 
COMMERCE 

HOUSE OF REPRESENTATDH]S 

ONE HUNDRED ELEVENTH CONGRESS 

FIRST SESSION 


SEPTEMBER 22, 2009 


Serial No. 111-66 



Printed for the use of the Committee on Energy and Commerce 
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COMMITTEE ON ENERGY AND COMMERCE 


HENRY A. WAXMAN, California, Chairman 
JOHN D. DINGELL, Michigan 
Chairman Emeritus 
EDWARD J. MARKEY, Massachusetts 


RICK BOUCHER, Virginia 
FRANK PALLONE, jR., New Jersey 
BART GORDON, Tennessee 
BOBBY L. RUSH, Illinois 
ANNA G. ESHOO, California 
BART STUPAK, Michigan 
ELIOT L. ENGEL, New York 
GENE GREEN, Texas 
DIANA DeGETTE, Colorado 
Vice Chairman 
LOIS CAPPS, California 
MICHAEL F. DOYLE, Pennsylvania 
JANE HARMAN, California 
TOM ALLEN, Maine 
JANICE D. SCHAKOWSKY, Illinois 
CHARLES A. GONZALEZ, Texas 
JAY INSLEE, Washington 
TAMMY BALDWIN, Wisconsin 
MIKE ROSS, Arkansas 
ANTHONY D. WEINER, New York 
JIM MATHESON, Utah 
G.K. BUTTERFIELD, North Carolina 
CHARLIE MELANCON, Louisiana 
JOHN BARROW, Georgia 
BARON P. HILL, Indiana 
DORIS O. MATSUI, California 
DONNA M. CHRISTENSEN, Virgin Islands 
KATHY CASTOR, Florida 
JOHN P. SARBANES, Maryland 
CHRISTOPHER S. MURPHY, Connecticut 
ZACHARY T. SPACE, Ohio 
JERRY McNERNEY, California 
BETTY SUTTON, Ohio 
BRUCE BRALEY, Iowa 
PETER WELCH, Vermont 


JOE BARTON, Texas 
Ranking Member 
RALPH M. HALL, Texas 
FRED UPTON, Michigan 
CLIFF STEARNS, Florida 
NATHAN DEAL, Georgia 
ED WHITFIELD, Kentucky 
JOHN SHIMKUS, Illinois 
JOHN B. SHADEGG, Arizona 
ROY BLUNT, Missouri 
STEVE BUYER, Indiana 
GEORGE RADANOVICH, California 
JOSEPH R. PITTS, Pennsylvania 
MARY BONO MACK, California 
GREG WALDEN, Oregon 
LEE TERRY, Nebraska 
MIKE ROGERS, Michigan 
SUE WILKINS MYRICK, North Carolina 
JOHN SULLIVAN, Oklahoma 
TIM MURPHY, Pennsylvania 
MICHAEL C. BURGESS, Texas 
MARSHA BLACKBURN, Tennessee 
PHIL GINGREY, Georgia 
STEVE SCALISE, Louisiana 


(II) 



Subcommittee on Oversight and Investigations 


BAET STUPAK, Michigan, Chairman 


BRUCE L. BRALEY, Iowa 
Vice Chairman 

EDWARD J. MARKEY, Massachusetts 

DIANA DeGETTE, Colorado 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

MIKE ROSS, Arkansas 

DONNA M. CHRISTENSEN, Virgin Islands 

PETER WELCH, Vermont 

GENE GREEN, Texas 

BETTY SUTTON, Ohio 

JOHN D. DINGELL, Michigan (ex officio) 


GREG WALDEN, Oregon 
Ranking Member 
ED WHITFIELD, Kentucky 
MIKE FERGUSON, New Jersey 
TIM MURPHY, Pennsylvania 
MICHAEL C. BURGESS, Texas 


(III) 




CONTENTS 


Page 

Hon. Bart Stupak, a Representative in Congress from the State of Michigan, 

opening statement 1 

Hon. Greg Walden, a Representative in Congress from the State of Oregon, 

opening statement 3 

Prepared statement 6 

Hon. Donna M. Christensen, a Representative in Congress from the Virgin 

Islands, opening statement 10 

Hon. Gene Green, a Representative in Congress from the State of Texas, 

opening statement 10 

Hon. John D. Dingell, a Representative in Congress from the State of Michi- 
gan, prepared statement 12 

Hon. Edward J. Markey, a Representative in Congress from the Common- 
wealth of Massachusetts, prepared statement 13 

Hon. Joe Barton, a Representative in Congress from the State of Texas, 

prepared statement 15 

Hon. Michael C. Burgess, a Representative in Congress from the State of 
Texas, prepared statement 18 

Witnesses 

Nancy Kingsbury, Ph.D., Managing Director, accompanied by Sushil Sharma, 
Assistant Director, Applied Research and Methods, U.S. Government Ac- 
countability Office 21 

Prepared statement 25 

Ronald M. Atlas, Ph.D., Co-Chair, Committee on Biodefense, American Soci- 
ety for Microbiology 34 

Prepared statement 37 


(V) 




FEDERAL OVERSIGHT OF HIGH- 
CONTAINMENT BIOLABORATORIES 


TUESDAY, SEPTEMBER 22, 2009 

House of Representatives, 

Subcommittee on Oversight and Investigations, 

Committee on Energy and Commerce, 

Washington, DC. 

The subcommittee met, pursuant to call, at 11:00 a.m., in Room 
2123, Rayburn House Office Building, Hon. Bart Stupak [chairman 
of the subcommittee] presiding. 

Present: Representatives Stupak, Christensen, Green, Walden, 
Burgess and Gingrey. 

Staff Present: Mike Gordon, Chief Investigative Counsel; Dave 
Leviss, Chief Oversight Counsel; Molly Gaston, Counsel; Scott 
Schloegel, Investigator; Jennifer Owens, Special Assistant; Paul 
Jung, Public Health Service Detailee; Lindsay Vidal, Special As- 
sistant; Jen Berenholz, Deputy Clerk; Mitchell Smiley, Special As- 
sistant; Matt Eisenberg, Staff Assistant; Alan Slobodin, Minority 
Counsel; Krista Rosenthall, Minority Counsel; and Peter Kielty, 
Minority Research Assistant. 

OPENING STATEMENT OF HON. BART STUPAK, A REPRESENT- 
ATIVE IN CONGRESS FROM THE STATE OF MICHIGAN 

Mr. Stupak. Today, we have a hearing titled Federal Oversight 
of High-Containment Biolabs. The chairman and ranking member 
will be recognized for 5-minute opening statements. Other mem- 
bers of the subcommittee will be recognized for 3-minute opening 
statements. 

Nearly 2 years ago, this subcommittee investigated some highly 
troubling issues related to high-containment biolabs, which are 
labs that handle some of the world’s most exotic and dangerous dis- 
eases, including anthrax, smallpox, foot and mouth disease and 
Ebola virus. 

On October 4, 2007, at a subcommittee hearing titled Germs and 
Viruses and Secrets: The Silent Proliferation of Biolabs in the 
United States, we focused on increasing the number of high-con- 
tainment biolabs, otherwise known as BSL-3 and BSL-4 labs. 

The accidental or deliberate release of the dangerous agents han- 
dled in those labs could have catastrophic consequences. At our 
hearing, we examined whether the Federal Government should be 
doing more to keep track of these labs and ensure that they follow 
sound safety and security practices. 

Since that hearing, important questions have remained alarm- 
ingly unanswered, such as, number one, how many high-contain- 

( 1 ) 



2 


ment labs exist in the United States and how many do we really 
need; two, how many labs had serious incidents in which lab work- 
ers or the public could have been exposed to dangerous diseases; 
three, how effective are the high-containment labs’ personnel reli- 
ability measures and inventory technology? What changes have 
been made to address the Department of Justice’s conclusion that 
a single Department of Defense employee caused the anthrax at- 
tacks of 2001? We asked the Government Accountability Office, 
GAO, to look into these issues, and today we will learn what they 
found. 

Unfortunately, many problems still exist such as no single agen- 
cy or office in the Federal Government keeps track of how many 
high-containment labs there are in the United States, where they 
are located, what types of research they are doing and whether 
they are safe and secure. In short, there still appears to be no ade- 
quate Federal plan or effort to manage, much less coordinate, high- 
ly dangerous research. There are no universal standards for lab de- 
sign, construction, or use. 

The Department of Health and Human Services publishes a 
guideline. Biosafety in the Biomedical and Microbiological Labora- 
tories, known as the BMBL. Labs that receive NIH grants must 
comply with BMBL guidelines, but private and other nonfederally 
funded facilities have no similar requirement. While labs that han- 
dle select agents must obtain Federal registration and certification, 
no accreditation or certification is required for labs working with 
dangerous organisms that are not on the select agent list, such as 
SAKS or West Nile Virus. 

There are no standards for biosafety training or the credentialing 
of high-containment laboratory workers. The Department of Health 
and Human Services only requires training of workers handling or- 
ganisms on the select agent list. There are no standards or mecha- 
nisms for ensuring involuntary control or personnel reliability. 

It is essential to lab security that lab workers undergo adequate 
screening and that the quantity of biological agents in a lab is 
tracked carefully. Failures in personnel reliability practices can be 
catastrophic. Again, the 2001 anthrax attacks, which the Depart- 
ment of Justice has said was the work of one Department of De- 
fense scientist, is a tragic example of this risk. 

Finally, the biolab community has no mechanism to catalogue ac- 
cidents and mishaps for collective analysis so lessons can be 
learned and shared to improve safety and security practices. 

Unfortunately, what is clear is that the Federal policy on bio- 
safety and security remains basically unchanged from what it was 
when we had our hearing 2 years ago. There is hope that this may 
change thanks to two reports that should be finalized hopefully in 
the next coming weeks. 

The first is the Trans-Federal Task Force on Optimizing Bio- 
safety and Biocontainment Oversight, which is cochaired by HHS 
and USDA, which was a direct result of our hearing 2 years ago. 
The task force report will make important recommendations for im- 
proving biosafety in the United States. 

Another such study by the Executive Order Working Group on 
Strengthening the Biosecurity of the United States, which was ere- 



3 


ated by President Bush’s executive order in January, will make rec- 
ommendations on ways to improve the select agent program. 

The committee staff has been briefed about the process for pre- 
paring these reports. It is hoped that these reports will be available 
in the next few weeks. I look forward to hearing from the adminis- 
tration on this important matter at that time. 

Today, we will hear testimony from the Government Account- 
ability Office about its findings and recommendations concerning 
biolab safety and security. Their report, titled High-Containment 
Laboratories: National Strategy for Oversight Is Needed, was re- 
leased yesterday. We will also hear from a representative of the 
American Society of Microbiology, who can share the perspective of 
those who operate and work directly with high-containment labs. 
I look forward to hearing the testimony of our witnesses regarding 
how we can quickly and responsibly address this challenge and en- 
hance our Nation’s biosafety and security. 

It is our hope that this new administration will act quickly to ap- 
prove data about labs and improve lab safety and security. 

Let me also express my condolences to the families and cowork- 
ers and friends of the tlniversity of Chicago professor, Malcolm 
Casabadan, who died last week from what appears to be an infec- 
tion that he may have acquired from the lab while doing research 
on the plague. This highlights the fact that even more needs to be 
done to protect our scientists and the public inside and outside the 
lab. 

With that, I will next turn to the gentleman from Oregon, Mr. 
Walden, please, for an opening statement. 

OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENT- 
ATIVE IN CONGRESS FROM THE STATE OF OREGON 

Mr. Walden. Thank you. Chairman Stupak. I appreciate the op- 
portunity to join you at this hearing today. 

I concur with your remarks and sympathies to the family of Mal- 
colm Casabadan, and I think it is important to note that this was 
a Level 2 lab. We are dealing with Level 3 and 4 in this hearing 
today. 

But it does raise the issue about how far down we need to go. 
And in this case, I guess they are still trying to figure out if the 
bacteria. Yersinia, that persisted in his blood that is related to the 
plague perhaps caused his death. And so, clearly, we need to be in- 
vestigating these safety issues in all of our country’s labs. 

I also say, Mr. Chairman, that the Republican staff has come to 
learn that the NIH, as part of their stimulus dollars, now may 
have received upwards of a billion dollars to more rapidly build out 
these labs, which I think raises the issue about our need to do 
proper oversight not only of how stimulus dollars are being spent 
here but elsewhere throughout the government so the taxpayers’ 
money is spent appropriately. So I would hope that our sub- 
committee would have a hearing on stimulus spending as it relates 
to the agencies under our purview. 

Yesterday, the Government Accountability Office released a re- 
port addressing some of the issues raised at our previous hearing 
regarding increased oversight and improved safety measures at 



4 


these types of laboratories; and they are here today to discuss their 
findings. I appreciate that. 

Just weeks after 9/11, our Nation faced a series of bioterrorist at- 
tacks where weapons-grade anthrax was delivered through the 
mail and five people died. Authorities now believe that one sci- 
entist who worked in one of our Nation’s high-containment labora- 
tories was responsible for those attacks. My office was in the Long- 
worth Building in those days, and we were shut out of our office 
because of the anthrax that came into that building. 

In response to the attacks. Congress increased funding to up- 
grade our Nation’s biodefense program. The National Institutes of 
Health, NIH, which funds much of the lab research and construc- 
tion, spent $1.7 billion in 2007, compared to $53 million on bio- 
defense labs in 2001. 

Now, that is a 32-fold increase in spending. Again, we under- 
stand that NIH is receiving stimulus dollars to add another billion 
dollars in spending for intramural/extramural facilities, and I think 
it will be important to note how that money is being spent, espe- 
cially with such a steep increase in funding and the rapid expan- 
sion of the lab network. It is time to reexamine the Federal regu- 
latory system to ensure safety and efficiency. 

Our hearing on October 4th of 2007 examined the results of the 
Bioterrorism Act on Federal oversight of select agents. It identified 
a few gaps and questioned how these labs and Federal regulations 
would mitigate risks while increasing our defenses. Now, it has 
been almost 2 years since our last hearing, and it is evident both 
the Federal Government and the academic realm agreed with the 
sense of the subcommittee’s hearing that there is a need for in- 
creased oversight and improved safety and security measures in 
high-containment laboratories. 

As a result of the October 2007 hearing, the Trans-Federal Task 
Force on Optimizing Biosafety and Biocontainment Oversight was 
created. That is cochaired by HHS and USDA, and their report, 
along with recommendations to improve oversight and safety, is 
scheduled to be released within the next week or two. 

In January, then-President Bush, as you mentioned, Mr. Chair- 
man, signed Executive Order 13486 which established the working 
group to examine how to strengthen laboratory biosecurity and 
safety in our Nation’s high-containment labs. Now, the working 
group’s report was completed and sent to the President in July; yet, 
to date, the administration has not publicly commented on nor re- 
leased the report nor made any formal recommendations. The com- 
mittee staff was told the administration has begun to collect and 
evaluate these reports and is in the preliminary stages of the policy 
process, yet a request for a briefing or a witness for the hearing 
from the White House was unanswered. 

GAO’s report highlights the pressing need for coordinated na- 
tional oversight of our Nation’s high-containment laboratories. 
GAO recommends the National Security Adviser name a single en- 
tity charged with government-wide strategic evaluation of high-con- 
tainment laboratories including tracking our lab capacity, evalu- 
ating our country’s needs and establishing our research priorities. 

There seems to be some consensus within the scientific commu- 
nity that we already have oversight infrastructures in place within 



5 


the Department of Health and Human Services and the Depart- 
ment of Agriculture. I hope the administration utilizes this existing 
expertise instead of creating a centrally located biosafety — or shall 
I call it a Germ Czar — at the White House. 

Other reports completed by the American Association for the Ad- 
vancement of Science and the National Science Advisory Board for 
Biosecurity were issued earlier this year. These reports discussed 
ways to increase safety and security in our Nation’s high-contain- 
ment labs, focusing on personnel reliability and enhancing training 
programs. A lot of research and reports have been completed by our 
government and academic associations, and we are appreciative of 
those, but some of these reports have not been finalized and made 
public. 

In turn, only Dr. Kingsbury from the GAO is here to discuss 
their report — which we appreciate — and answer our questions. But 
these facts suggest to me that this committee might have been bet- 
ter served by delaying this hearing for a week or two so we could 
have all of the reports before us before they were released, and var- 
ious responsible Federal agencies could also send witnesses to give 
us a more complete view of what we face. 

The oversight of our Nation’s high-containment laboratories is an 
issue that is deserving of this subcommittee’s attention. However, 
this hearing is not inclusive, I believe, or representative of all the 
work that has been done in this area, and we need to keep that 
in mind as we proceed. 

I do want to welcome Dr. Atlas from the American Society of 
Microbiology, which has more than 40,000 members. We appreciate 
your being here representing the science and health professionals 
who staff these labs. Your input will be very valuable. 

He will discuss the important roles these laboratories play in 
protecting our Nation, the importance of biosafety requirements for 
the labs and their personnel, and recommendations to improve bio- 
safety training, oversight, resources, reporting, and biosecurity. 

Thank you, Mr. Chairman, for holding this hearing. I look for- 
ward to working with you on this issue in the weeks ahead. 

[The prepared statement of Mr. Walden follows:] 



6 


Opening Statement of the Honorable Greg Walden 
Ranking Member, Subcommittee on Oversight and Investigations 
“Federal Oversight of High Containment Bio-Laboratories” 
September 22, 2009 

Thank you, Chairman Stupak. I am pleased to join you in continuing 
this subcommittee’s investigation into the safety and security issues 
surrounding our nation’s high-containment laboratories. These kinds of 
facilities are known as bio-safety Level 3 and 4 laboratories, and they 
conduct research on highly infectious viruses and other biological agents. 
Yesterday, the Government Accountability Office (GAO) released a report 
addressing some of the issues raised at our previous hearing regarding 
increased oversight and improved safety measures at these laboratories, and 
they are here today to discuss their findings. 

Just weeks after 9/11, our nation faced a series of bio-terrorist attacks 
where weapons-grade anthrax was delivered through the mail. Five people 
died. Authorities now believe that one scientist who worked in one of our 
nation’s high-containment laboratories was responsible for these attacks. 

In response to the attacks. Congress increased funding to upgrade our 
nation’s bio-defense program. The National Institutes of Health (NIH), 
which fund much of the lab research and construction, spent about $1.7 
billion in 2007 compared to spending $53 million on bio-defense labs in 
2001. This represents a 32-fold increase in spending. (Recently, Minority 
Committee staff was told that some of the money NIH received as part of the 
national stimulus package is providing a boost to these high-containment 
labs.) With such a steep increase in funding and rapid expansion of the lab 
network, it was time to re-examine the federal regulatory^ system to ensure 


1 



7 


safety and efficiency. Our hearing on October 4, 2007 examined the results 
of the Bioterrorism Act on federal oversight of select agents, identified a few 
gaps, and questioned how these labs and federal regulations would mitigate 
risk while increasing our defenses. 

It has been almost two years since our last hearing and it is evident 
that both the federal government and the academic realm agreed with the 
sense of the subcommittee’s hearing that there is a need for increased 
oversight and improved safety and security measures in high-containment 
laboratories. 

As a result of the October 2007 hearing, the Trans-Federal Task Force 
on Optimizing Bio-safety and Bio-containment Oversight was created, co- 
chaired by HHS and USDA, and their report along with recommendations to 
improve oversight and safety is scheduled to be released within the next 
week or two. In January, then President Bush signed Executive Order 13486 
which established a working group to examine how to strengthen laboratory 
bio-security and safety in our nation’s high-containment labs. The working 
group’s report was completed and sent to President Obama in July. To date, 
the Administration has not publicly commented on or released the report or 
made any formal recommendations. Committee staff was told that the 
Administration has begun to collect and evaluate these reports and is in the 
preliminary stages of the policy process, yet a request for a briefing or 
witness for the hearing from the White House was unanswered. 

GAO’s report highlights the pressing need for coordinated national 
oversight of our nation’s high-containment laboratories. GAO recommends 
that the National Security Advisor name a single entity charged with 
government wide strategic evaluation of high-containment laboratories 
including tracking our lab capacity, evaluating our needs, and establishing 


2 



8 


our research priorities. There seems to be some consensus within the 
scientific community that we already have oversight infrastructures in place 
within the Departments of Health and Human Services and the Department 
of Agriculture. I hope that the Administration utilizes this existing expertise, 
instead of a creating a centrally located Bio-Safety or Germ Czar at the 
White House. 

Other reports completed by the American Association for the 
Advancement of Science and the National Science Advisory Board for Bio- 
security were issued earlier this year. These reports discuss ways to increase 
safety and security in our nation’s high-containment labs focusing on 
personnel reliability and enhancing training programs. 

A lot of research and reports have been completed by our government 
and academic associations, but some of these reports have not been finalized 
and made public. In turn only Dr. Kingsbury from the GAO is here to 
discuss their report and answer our questions. These facts suggest to me that 
this committee might have been better served by delaying this hearing for a 
week or two until all of these reports were released and the various 
responsible federal agencies could send witnesses to provide a full 
compliment of viewpoints and discuss possible implementation ideas. The 
oversight of our nation’s high-containment laboratories is an issue worthy of 
this subcommittee’s attention; however this hearing is not inclusive or 
representative of all the work that has been done in this area. 

1 do want to welcome Dr. Atlas from the American Society for 
Microbiology, which has over 40,000 members, who is here as a 
representative of the scientists and health professionals who staff these labs. 
He will discuss the import role these laboratories play in protecting our 
nation, the importance of bio-safety requirements for the labs and its 


3 



9 


personnel, and recommendations to improve bio-safety training, oversight, 
resources, reporting, and bio-security. 

Thank you Mr. Chairman. I want to welcome and thank the witnesses 
for testifying today. 


4 



10 


Mr. Stupak. Ms. Christensen, opening statement, please? 

OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN, A 
REPRESENTATIVE IN CONGRESS FROM THE VIRGIN ISLANDS 

Mrs. Christensen. Thank you, Mr. Chairman, and thank you to 
you and Mr. Walden. I really appreciate the opportunity to take a 
second look at the lack of oversight on high-containment biolahs. 

I recall from my time on the Committee on Homeland Security, 
when the National Institute of Allergy and Infectious Disease testi- 
fied that they were in the process of building the two laboratories; 
and I am amazed to see how the number has grown in the public, 
academic and private sectors. But I am very concerned that — as I 
am sure are you, that there is no one agency that can tell us how 
many of these labs there are, and that some of the same uncertain- 
ties about what is exposure, how best to train and certify employ- 
ees still exist. Not much seems to have changed since the 2007 re- 
port and hearing. 

We all realize that we have to balance stimulating and sup- 
porting research with providing regulatory oversight, but the ful- 
crum really has to be the safety of the employees, the surrounding 
communities, and our country. 

I look forward to the testimony. I thank Dr. Kingsbury and Dr. 
Atlas for being here today. 

Mr. Stupak. Mr. Green. 

OPENING STATEMENT OF HON. GENE GREEN, A 
REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. Green. Thank you, Mr. Chairman, for holding the hearing 
on the Federal oversight of the high-containment biolabs in the 
U.S. This hearing is a follow-up one held by our committee in 2007. 
I look forward to hearing the testimony from the witnesses on the 
Federal oversight of the safety systems of these biolabs and how we 
can improve our evaluation and tracking section. 

In Texas, the University of Texas Medical Branch at Galveston 
National Lab is one of the two national biocontainment laboratories 
constructed under grants awarded by the National Institute of Al- 
lergy and Infectious Disease, the National Institutes of Health. And 
I am proud to have much of this research being performed literally 
in the backyard of UTMB at Galveston. At this BSL-4 lab, re- 
search is conducted to develop therapies and vaccines and tests for 
diseases like anthrax, avian influenza, bubonic plague, Ebola, ty- 
phus, West Nile Virus, and tuberculosis. As a Nation, we need this 
work performed. 

During my visits to UTMB, I learned firsthand about the meas- 
ures that UTMB is taking to ensure that that lab is built with 
every contingency in mind, and I also learned about the com- 
prehensive training program UTMB has in place. 

I have a personal interest in the safety of biolabs because my 
daughter completed her fellowship at UTMB, and she worked some 
of the research conducted on the select agents at the operational 
BSL-4 and in that Galveston National Lab when it was completed. 
Due to the damage to the UTMB campus from Hurricane Ike, she 
unfortunately left Galveston, and now she is at the University of 
Nebraska working in infectious diseases. 



11 


But I also know that during Hurricane Ike that lab was the 
safest place to be on the Galveston Island. There was no loss, no 
exposure, and just a success on what had been done for a number 
of years; and the center grew even more. It withstood a Category 
4 hurricane on a barrier island, so I think it is built pretty well. 

As a parent to a researcher, I want to make sure that these bio- 
safety labs adhere to higher safety training standards wherever 
they may be; and it was a source of personal comfort that UTMB 
had placed such an emphasis on safety training, safety of these 
labs across the U.S. Given the growth of these labs nationwide, I 
think we need to step up our safety training efforts, as well as 
structure within the existing agency, such as HHS or the Depart- 
ment of Agriculture, to track the growth of these labs. 

I appreciate the witnesses here today. And my other hat, I serve 
on the Health Subcommittee, and a lot of those illnesses that these 
biolabs are working on are ones that we hope to be able — we hope 
they will never have to treat our constituents. But we also know 
in this world they may have to, so we need those labs here, doing 
their job. 

Mr. Stupak. For other members — and I know Chairman Wax- 
man and others have submitted opening statements — their state- 
ments will be made part of the record. 

[The prepared statements of Messrs. Dingell, Markey, Barton, 
and Burgess follow:] 



12 



Subcommittee on Oversight and Investigations 
Hearing on “Federal Oversight of High Containment Bio-Laboratories” 
Opening Statement of the Honorable John D. Dingell 
September 22, 2009 

Chairman Stupak, thank you for holding this hearing today on the challenges of and the 
need for providing oversight of high containment, also known as biosafety level (BSL)-3 
and BSL 4, bio-laboratories in the United States. I am pleased the Committee is 
continuing its investigation into the world of high containment bio-laboratories that 
began in 2007. I also want to thank our witnesses, who provided useful insights and 
recommendations from which the Congress can determine the need for legislative action. 

It is clear that high containment bio-laboratories are not only important for basic research 
of infectious diseases, but especially after September 1 1 and the anthrax attacks of 2001, 
they are a necessary component of our national effort to combat biological terrorism. 
However, in light of the Government Accountability Office (GAO) Report released 
yesterday and the testimony we will hear today, there is still an unsettling gap in federal 
oversight of high containment labs, which perform research on dangerous pathogens and 
emerging infectious diseases. For example, GAO testimony states there is no federal 
agency that is knows the total number nor whose mission is to track the expansion of high 
containment laboratories. Thus, it is unclear whether we have a too few, enough, or too 
many of these laboratories in the U.S. Further, there is no national personnel training 
requirement for workers, personnel reliability standards to counter insider threats, nor is 
there a design, construction, and maintenance standard for these laboratories. 

I would like to highlight one particular incident in the GAO report which relates to 
concerns I have expressed regarding the handling and research of Foot and Mouth 
Disease, a highly infectious animal disease. GAO reports that an accidental release of 
Foot and Mouth Disease in the United Kingdom was likely caused by poor maintenance 
of a bio containment facility coupled with a lack of clear lines of responsibility regarding 
the maintenance of shared infrastructure facilities. That outbreak caused U.K. taxpayers 
over $3 billion. The incident underscores some of the dangers about the proposed 
National Bio- and Agro- Defense (NBAF) Laboratory to be constructed in Manhattan, 
Kansas, which will house research of FMD. Any release of FMD, whether an intentional 
insider release or accidentally caused by human error, poor construction or maintenance, 
could cause tens of billions of dollars in damage to our domestic livestock industty'. The 
gaps identified in the GAO report regarding the lack guidelines for design, construction, 
maintenance, personnel reliability, and worker training further illustrate that we must be 
extremely cautious in deciding whether to build the NBAF in Kansas or any other high 
containment laboratories in the U.S. 

I look forward to hearing our witness testimony which will help this Committee and the 
Congress best determine the next steps for oversight of high containment bio laboratories 
in the U.S. 



13 


Statement of Rep. Edward J. Markey 
Oversight and Investigations Subcommittee Hearing on 

Federal Oversight of High Containment Bio-Laboratories 

September 22, 2009 

Thank you, Mr. Chairman, for holding today’s hearing on the 
government’s oversight, or lack thereof, of high containment 
biological laboratories. 

First of all, I would like to say that I am a longstanding supporter 
of biomedical research. I believe that medical research allows us to 
harvest cures from science’s field of dreams, reaping enormous 
benefits for our society. Biomedical research that is conducted 
safely and ethically improves human health, strengthens our 
economy, and ultimately, saves lives. 

Since the tragic anthrax attacks of 2001 , our nation’s research 
community has geared up to better prepare us against the very real 
threat of biological agents. The Bush administration increased 
research funds, workforce size, and the overall number of 
laboratories to go to battle against these agents. But they made 
these increases without a coordinated plan of attack, without 
keeping track of their work, and without mechanisms to evaluate 
their progress. That’s like hitting the field for a football game 
without a playbook! They were unprepared and uncoordinated and 
this led to serious problems. 

We learned in the last hearing on biolab safety in this 
subcommittee that our nation’s biological laboratories are fraught 
with security and safety problems, endangering the safety and 
well-being of Americans who live in the vicinity of these 
laboratories. And recent revelations that the 2001 anthrax attacks 
were carried out by a scientist at a federal government laboratory 
raise additional questions about how effectively the government 
can oversee facilities it doesn’t own or operate itself 



14 


One of the newest high containment facilities is being built by 
Boston University in my home state, right in downtown Boston. 
This facility will include laboratories classified as Biosafety Level 
4 , which means that it will contain pathogens that have no cure, 
like the Ebola virus and the plague. 

As you can imagine, some residents of Boston were not too 
pleased to have the plague right in their backyard, even though it is 
contained is a facility that’s designed to be extremely secure. And 
imagine how they felt when the National Academies announced 
that the safety review conducted by Boston University was grossly 
inadequate, not scientifically sound, and not credible. 

Thankfully, the former director of the NIH, Dr. Elias Zerhouni, 
intervened and pulled together a blue ribbon panel of science and 
safety experts to complete a thorough evaluation of the safety of 
the Boston lab. 

The problems with the safety evaluation of the Boston University 
lab highlight the need for national coordination, planning, and 
oversight of high containment bio-labs. I look forward to today’s 
testimonies and I hope that the GAO’s recommendations are 
adopted by the time the Boston lab opens up next year. 



15 


Opening Statement of the Honorable Joe Barton 
Ranking Member, Committee on Energy and Commerce 

Subcommittee on Oversight and Investigations Hearing: 

“Federal Oversight of High Containment Bio-Laboratories” 
September 22, 2009 

Thank you. Chairman Stupak and Ranking Member Walden, for holding this 
hearing. This is our second hearing on the safety and security at our nation’s high- 
containment laboratories. It has been almost two years since our initial hearing, and I 
look forward to hearing what actions have been taken by the federal government and the 
private sector to address some of the issues we raised at our last hearing to improve the 
safety and security at these labs. 

In response to 9-1 1, the anthrax attacks, and the emerging threat of bio-terrorism, 
Congress passed the Bioterrorism Act in 2002. Among other things, this Act established 
a regulatory system at the Centers for Disease Control over the possession, use, and 
transfer of select agents and toxins. We also dramatically increased spending for 
building and expanding laboratories that research deadly germs and toxins. With 
increased funds and new regulations, high containment laboratories’ safety and security 
and personnel assurance measures were re-evaluated. These labs have to maintain a 
robust research agenda while simultaneously protecting the public and their own workers 
from the inherent dangers involved in researching dangerous pathogens. Strict safety 
rules and guidelines are required to protect against leaks, losses, or theft of these deadly 
materials. 


1 



16 


This hearing re-examines several issues raised at our 2007 hearing. The 
Government Accountability Office issued a report yesterday once again highlighting the 
need for improved and coordinated federal oversight of high containment laboratories. 
Several other reports have either been issued or are about to be released. These include 
reports by the National Science Advisory Board for Bio-security and the American 
Association for the Advancement of Science, as well as a report by the Trans-Federal 
Task Force on Optimizing Bio-safety and Bio-containment Oversight. In addition, 
former President Bush signed Executive Order 13486 in January which established a 
working group to examine how to strengthen laboratory bio-security and safety in our 
nation’s high-containment labs. The working group’s report was completed and sent to 
President Obama in July. To date, the Administration has not publicly commented on the 
report or recommendations. Committee staff contacted the National Security Council 
and requested a briefing and or testimony for today’s hearing, but no response was given. 

Over the past two years, it appears that invested parties from the government and 
academia have been examining ways to increase oversight and safety. Congress and the 
President need to work together to develop a policy that is both protective of the public 
health as well as conducive to maintaining a strong network of high-containment labs and 
scientists. 

While we discuss the possible gaps in federal and institutional oversight of high 
containment laboratories, we should also realize that the work performed in these high- 
risk laboratories is critical to our nation’s defense and health. Dedicated scientists and 
lab staff conduct truly critical research into bio-defense and vaccines in these labs. One 
day, the work they do may save the lives of millions. One of our witnesses today is Dr. 


2 



17 


Atlas from the American Society for Microbiology. He will offer a valuable perspective 
as a representative of those who work in the field. 

I believe that the government, the private sector, and universities can figure out 
how to conduct research into the agents of bioterrorism and that they can also figure out 
how to protect lab workers and the public at the same time. Our country needs both of 
those jobs done, and done well. 

Thank you, Mr. Chairman. I welcome all the witnesses. 


3 



18 


STATEMENT OF 

CONGRESSMAN MICHAEL C. BURGESS, M.D. 
BEFORE THE 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS 
COMMITTEE ON ENERGY AND COMMERCE 

SEPTEMBER 22, 2009 HEARING 
“Federal Oversight of High Containment Bio-Laboratories” 


For several weeks now, I have been awaiting an O&I hearing my 
good friend Bart Stupak had noticed regarding moving bio-security 
research from Plum Island inland. I’m not sure what Speaker 
Pelosi is doing but instead of giving Bart a hearing on Plum Island 
like he noticed, we get a hearing on bio-laboratories as a whole. 

And what did we get from the delay in timing and overbroad topic? 

Nothing. This hearing can hardly be considered well thought-out 
and executed. 

On September 15, 2009 we had a vote on H. Res. 317 recognizing 
Kansas as the appropriate state for the National Bio and Agro- 
defense Facility, with the language of the resolution proudly 
touting that 45% of the fed cattle in the United States and 40% of 
the hogs produced in this country are in Kansas. Considering that 
food-and-mouth disease, which is the primary research being done 
at Plum Island, is a disease which can spread with devastating 
swiftness from humans to cattle and hogs ... shouldn’t we have 
done our O&I hearing on the scientific evaluations being done at 
DHS before we voted on a resolution saying that Kansas was the 
best pick? 

In fact, the GAO stated that foot-and-mouth disease research 
shouldn’t be moved inland for this very reason — and certainly not 
to an area with lots of cattle and hogs! 



19 


I’m glad I voted against that resolution for that very reason. We 
need to have some common sense here in Congress. 

Also, what is Nancy Pelosi doing putting forth an O&I hearing on 
an issue which touches DHS, USDA, HHS, CDC and The White 
House’s NSA - not to mention the private sector - with one 
witness from the GAO and one witness from the private sector and 
no one from the federal government? 

We already have an Executive Working Group on this very topic 
who, in July, sent to President Obama a report on “Strengthening 
the Bio-security of the United States’’ as well as a Trans-Federal 
Task Force on “Optimizing Bio-safety and Bio-containment 
Oversight.” 

Why could we not have had these reports paneled before us today 
and not just the GAO?? 

Our committee is not a classroom for mere esoteric discussion and 
thought. We are not interested in purely academic conversation 
about omnibus changes to an issue which clearly has simply been 
suffering from merely a lack of communication and basic 
oversight. 

For instance, today’s GAO report states that twelve federal 
agencies play a role in our biodefense, but information about what 
they are doing are unknown. Why is this? Don’t these federal 
agencies have phones and emails? Can’t they just go and have 
meetings with each other and tell them what they are doing? Why 
do they need a Biodefense CZAR on top of DHS and The White 
House to coordinate information? 

I am deeply disturbed by the notion put forth by the GAO that 
there needs to be YET ANOTHER layer of oversight for our 



20 


federal government when it comes to our homeland security. After 
all, we have given them the legal authority under BARDA and tens 
of billions of dollars of hard-earned taxpayer dollars to function . If 
they aren’t functioning, then we need to have them here and held 
accountable. 

Thank you. 



21 


Mr. Stupak. That concludes the opening statements by members 
of the committee. I now call our witnesses. 

On our panel we have Dr. Nancy Kingsbury, who is the Man- 
aging Director of Applied Research and Methods at the U.S. Gov- 
ernment Accountability Office; Dr. Sushil Sharma with the GAO; 
and Dr. Ronald Atlas, who is the cochair of the Committee on Bio- 
defense at the American Society for Microbiology. 

STATEMENTS OF NANCY KINGSBURY, Ph.D., MANAGING DI- 
RECTOR, ACCOMPANIED BY SUSHIL SHARMA, ASSISTANT DI- 
RECTOR, APPLIED RESEARCH AND METHODS, U.S. GOVERN- 
MENT ACCOUNTABILITY OFFICE; AND RONALD M. ATLAS, 

Ph.D., CO-CHAIR, COMMITTEE ON BIODEFENSE, AMERICAN 

SOCIETY FOR MICROBIOLOGY 

Mr. Stupak. Welcome to our witnesses. 

It is the policy of this subcommittee to take all testimony under 
oath. Please be advised that you have a right under the rules of 
the House to be advised by counsel during your testimony. Do you 
wish to be represented by counsel? 

Everyone is indicating “no.” 

All right. Then I am going to ask you to please rise, raise your 
right hand and take the oath. 

[Witnesses sworn.] 

Mr. Stupak. The witnesses replied in the affirmative. 

We will hear a 5-minute opening statement from our witnesses. 
You may also submit a longer statement, and it will be in the 
record. 


STATEMENT OF NANCY KINGSBURY, Ph.D. 

Ms. Kingsbury. Mr. Chairman and members of the sub- 
committee, we are very pleased to be here to discuss our report on 
the national strategy for high-containment laboratories in the 
United States that deal with dangerous pathogens. Our report on 
those matters was released yesterday, as you mentioned in your 
opening statements. 

Such high-containment laboratories have proliferated in recent 
years. This report focuses on the proliferation in the West, but 
similar things are done in other countries. 

In 2007, we reported on several issues associated with the pro- 
liferation of these labs in the United States and some of these risks 
posed by biosafety incidents that occurred in the past. The FBI’s 
allegation in August 2008 that a DOD scientist was the sole perpe- 
trator of the 2001 anthrax attacks raised additional concerns about 
the possibility of insider misuse of high-containment lab facilities, 
materials and technology. Highly publicized laboratory errors and 
controversies about where high-containment labs should be located 
had raised questions about whether the governing framework, 
oversight and standards for biosafety and biosecurity are adequate. 

In this context you asked us to address the following questions: 

To what extent and in what areas has the number of high-con- 
tainment labs increased in the United States? 

Which Federal agency is responsible for tracking the expansion 
of high-containment laboratories in determining the associated ag- 
gregated risks? 



22 


And what lessons can be learned from highly publicized incidents 
at high-containment laboratories and actions taken by the regu- 
latory agencies? 

We have three basic findings to report: 

First, since 2001 the number of BSL-3 and BSL-4 labs in the 
United States has increased, and this expansion has taken place 
across Federal, State, academic and private sectors. Information 
about the number, location, activities and ownership is available 
for high-containment laboratories that are registered with CDC’s or 
USDA’s select agent programs, but not for those outside those pro- 
grams. 

The expansion that began after the anthrax attacks in 2001 
lacked a clear, coordinated national strategy. Decisions to fund con- 
struction of high-containment labs were made by multiple Federal 
agencies in multiple budget cycles. Federal and State agencies, aca- 
demia and the private sector considered their individual require- 
ments, but an assessment of national need was lacking. Even now, 
after more than 7 years, we were unable to find any projections 
based on a government-initiated strategic evaluation of current and 
future capacity requirements linked to national public health goals. 
Such information is needed, we think, to ensure that the U.S. will 
have facilities in the right place with the right research capabili- 
ties. 

Second, no executive or legislative mandates directs any single 
Federal agency to track the expansion of all high-containment labs. 
Accordingly, no Federal agency knows how many such labs exist in 
the United States and no single agency is responsible for deter- 
mining or are able to determine the aggregate risks associated with 
the expansion of these labs. Consequently, no Federal agency can 
determine whether high-containment lab capacity is now less than, 
meets or exceeds the national need. 

Finally, four highly publicized biosafety incidents in high-con- 
tainment labs, as well as evidence in scientific literature, dem- 
onstrate that while laboratory accidents are rare, they do occur, 
primarily due to human error or systems failures. 

One of the incidents we reviewed involved the allegations that 
Dr. Bruce Ivins of DOD was the source of the 2001 anthrax attack. 
These allegations highlighted two lessons: First, an ill-intentioned 
insider could pose a risk by removing dangerous material from a 
high-containment lab; and second, it is impossible to have 100 per- 
cent effective inventory control of biological material with currently 
available technologies. Such inventory control is possible for nu- 
clear material and for chemical material, but because biological 
material grows and expands, there are currently no available tech- 
nologies. 

At Fort Detrick, USF procedures for the control of inventories 
and the unrestricted use of lab facilities allegedly allowed Dr. Ivins 
the opportunity to pursue his own ends. As the number of high-con- 
tainment labs increases, there will inevitably be an increase in the 
pool of scientists with expertise, and thus, the corresponding risk 
from insiders is likely to increase. 

Taken as a whole, these incidents we reviewed demonstrate fail- 
ure of systems and procedures meant to maintain biosafety in high- 
containment labs. They reveal the failure to comply with regulatory 



23 


requirements that were not commensurate with the level of risk to 
public health posed by the lab workers and the pathogens in the 
lab, and the failure to fund ongoing facility maintenance and mon- 
itor the operational effectiveness of lab physical infrastructure. 

In conclusion, I want to stress that oversight plays a critical role 
in improving biosafety and ensuring that high-containment labs 
comply with regulations. However, some aspects of the current 
oversight programs provided by the CDC and USDA are dependent 
upon entities monitoring themselves and reporting incidents to 
Federal regulators. 

Furthermore, personnel reliability programs have been estab- 
lished by 2001 to counter insider risks, but their cost, effectiveness 
and problematic impact has not been evaluated. 

If an agency were tasked or a mechanism were established with 
the purpose of overseeing the expansion of high-containment labs, 
it could develop a strategic plan to ensure that the number and ca- 
pabilities of potentially dangerous high-containment labs are no 
greater or no less than necessary. It could balance the risks and 
benefits of expanding such labs and it could determine the type of 
oversight needed. 

To address these issues we recommended that the National Secu- 
rity Adviser, in consultation with the Secretaries of Health and 
Human Services, Agriculture, Defense, and Homeland Security, 
and the National Intelligence Council and any other departments 
and agencies that are appropriate, identify a single entity charged 
with periodic strategic evaluation of high-containment labs that 
will determine the number, location and mission of laboratories 
needed to effectively meet national goals to counter biothreats, the 
existing laboratory capacity within the United States, the aggre- 
gate lists associated with the expansion and the type of oversight 
needed. 

It could also develop in consultation with the scientific commu- 
nity national standards for the design, construction, commissioning 
and operation of high-containment laboratories, specifically includ- 
ing provisions for long-term maintenance, which is an area that we 
are quite concerned about. 

We also recommended that the Secretaries of Health and Human 
Services and Agriculture develop a clear definition of exposure to 
select agents — some of these incidents suggest that there is some 
confusion in that regard — and a mechanism for sharing lessons 
learned from reported laboratory accidents so that best practices 
for other operators for high-containment laboratories can be identi- 
fied and distributed. 

Recognizing that biological inventories cannot be completely con- 
trolled at present, we also recommended that the Secretaries of 
HHS and Agriculture review existing inventory control systems 
and invest in and develop appropriate technologies to minimize the 
potential for insider misuse of biological agents. 

Finally, should the Secretaries consider implementing a more 
stringent personnel of liability program for high-containment lab- 
oratories, employees to deal with insider risks, we recommended 
that they evaluate and document the cost effectiveness and pro- 
grammatic impact of such a program. 



24 


We did obtain written comments on the draft of our report from 
the Secretaries of Health and Human Services and Agriculture. 
HHS and Agriculture concurred with our recommendations that 
were directed to them. The Executive Office of the President and 
the National Security Council did not provide any comments. 

Mr. Chairman, this concludes my prepared remarks, and I will 
be happy to answer any questions that you or your colleagues may 
have. 

Mr. Stupak. Thank you. 

[The prepared statement of Ms. Kingsbury follows:] 



25 


GAO 

United States Government Accountability Office 

Testimony 

Before the Subcommittee on Oversight 
and Investigations, Committee on Energy 
and Commerce, House of Representatives 

For Release on Delivery 

Expected at 11:00 a.m. EDT 
Tuesday, September 22, 2009 

HIGH-CONTAINMENT 

LABORATORIES 


National Strategy for 
Oversight Is Needed 


statement of Nancy Kingsbury, Ph.D. 

Managing Director 

Applied Research and Methods 


A GAO 

Accountability * Integrity * Reliability 


GAO-09-1036T 



26 


Mr. Chairman and Members of the Subcommittee 

We are pleased to be here to discuss our report on a national strategy for 
high-containment laboratories that deal with dangerous pathogens — also 
known as biosafety Ievel-3 (BSL-S) laboratories and biosafety level-4 (BSL- 
4) laboratories — in the United States, which was released yesterday. ‘ The 
number of high-containment laboratories working with dangerous 
biological pathogens have proliferated in recent years. In 2007, we 
reported on several issues associated with the proliferation of high- 
containment laboratories in the United States, including risks posed by 
biosafety incidents that have occurred in the past.^ The Federal Bureau of 
Investigation’s allegation in August 2008 that a scientist at the U.S. Army 
Medical Research Institute of Infectious Diseases was the sole perpetrator 
of the 2001 anthrax attacks raised additional concerns about the 
possibility of insider misuse of high-containment laboratory facilities, 
material, and technology. The public is concerned about these laboratories 
because the deliberate or accidental release of biological agents can have 
disastrous consequences by exposing workers and the public to dangerous 
pathogens. Highly publicized laboratory errors and controversies about 
where high-containment laboratories should be located have raised 
questions about whether the governing framework, oversight, and 
standards for biosafety and biosecurity measures are adequate.® In this 
context, you asked us to address the following questions; ‘ 

1. To what extent, and in what areas, has the number of high- 
containment laboratories increased in the United States? 

2. Which federal agency is responsible for tracking the expansion of high- 
containment laboratories and determining the associated aggregate 
risks? 


‘ GAO, High-ContainiTtmt Laboratories: National Strategy for Oversight Is Needed. 
GAO-09-574 (Washington, D.C.: Sept 21, 2009). 

^GAO, High-Containment Biosafety Laboratories: Preliminary Observation on the 
Oversight of the Proliferation of and BSL-4 Laboratories in the United States, 

(iAO-Oa-lOST (Washington, D.C.: Oct 4, 2007). 

®G.K. Gronv^ et al., “Letter to Senator Edward Kennedy and Senator Richard Burr," 
Center few BirKecurity, University of Pittsburgh Medical Center, March 3, 2009. 

■*The reque^ letter contained several questions. In agreement with our requestor, we 
revised the questions as stated. 


Page i 


GAO-09-1036T 




27 


3. What levins can be learned from highly publicized incidents at high- 
containment laboratories and actions taken by the regulatory 
agencies? 

To answer these questions, we interviewed federal agency officials as well 
as experts in microbiology, reviewed literature, conducted site visits, and 
surveyed 12 federal agencies to determine if they have a mission to track 
high-containment laboratories in the United States. We also interviewed 
officials from relevant intelligence agencies to determine if they have a 
mission to determine insider risks in high-containment laboratories. The 
expert panel that reviewed this report comprised scientists witli 
substantive expertise in microbiological and select agent research and the 
operation of high-containment laboratories. 

We conducted our work from September 2005 through June 2009 in 
accordance with generally accepted government auditing standards. Those 
standards require that we plan and perform the audit to obtain sufficient, 
appropriate evidence to provide a reasonable basis for our findings and 
conclusions based on our audit objectives. We believe that the evidence 
obtained provides a reasonable basis for our findings and conclusions 
based on our audit objectives. 


The Number of High- 
Containment 
Laboratories Is 
Increasing in 
Different Sectors 
throughout the United 
States 


We found that since 2001, the number of BSLr4 and BSL-3 laboratories in 
the United States has increased, and this expansion has taken place across 
federal, state, academic, and private sectors and throughout the United 
States. Federal officials and experts believe that while the number of BSL- 
4 laboratories in the United States is known, the number of BSL-3 
laboratories is unknown. Information about the number, location, 
activities, and ownership is available for high-containment laboratories 
that are registered with the Centers for Disease Control and Prevention’s 
(CDC) Division of Select Agents and Toxins (DSAT) or the United States 
Department of Agriculture’s (USDA) Animal and Plant Health and 
Inspection Service (APHIS) select agent programs, but not for those 
outside the program. The recent expansion of high-containment 
laboratories in the United States began in response to the need to develop 
medical countermeasures and better risk evaluations after the anthrax 
attacks in 2001. Understandably, the expansion initially lacked a clear, 
govemmentwide coordinated strategy. In that emergency situation, the 
expansion was based on individual agency perceptions of requirements 
relative to the capacity their high-containment labs required as well as the 
availability of congressionaliy appropriated funding. Decisions to ftmd the 
construction of high-containment labs were made by multiple federal 


Page 2 


GAO-09-I036T 



28 


agencies in multiple budget cycles. Federal and state agencies, academia, 
and the private sector considered their individual requirements, but an 
assessment of national needs was lacking. Even now, after more than 7 
years, GAO was unable to find any projections based on a 
govemmentwide strategic evaluation of future capacity requirements set 
in light of existing capacity; the numbers, locations, and missions of the 
laboratories needed to effectively counter biothreats; and national public 
health goals. Such information is needed to ensure that the United States 
will have facilities in the right place with the right specifications. 


No Federal Agency 
Has the Mission to 
Track the Expansion 
of All High- 
Containment 
Laboratories and 
Regulate Biosafety in 
the United States 


Currently, no executive or legislative mandate directs any federal agency 
to track the expansion of all high-containment laboratories. Because no 
federal agency has the mission to track the expansion of BSL-3 and BSL-4 
laboratories in the United States, no federal agency knows how many such 
laboratories exist in the United States. While there is a consensus among 
federal agency officials and experts that some degree of risk is always 
associated with high-containment laboratories, no one agency is 
responsible for determining, or able to determine, the aggregate or 
cumulative risks associated with the expansion of these high-containment 
laboratories. As a consequence, no federal agency can determine whether 
high-containment laboratory capacity may now meet or exceed the 
national need or is at a level that can be operated safely. 


Lessons Learned from 
Four Incidents 
Highlight the Risks 
Inherent in the 
Expansion of High- 
Containment 
Laboratories 


Four highly publicized incidents in high-containment laboratories, as well 
as evidence in the scientific literature, demonstrate that (1) while 
laboratory accidents are rare, they do occur, primarily because of human 
error or systems (management and technical operations) failure, including 
the failure of safety equipment and procedures; (2) insiders can pose a 
risk; and (3) it is difficult to control inventories of biological agents with 
currently available technologies. It has been suggested that personnel 
reliability programs would mitigate the insider risk. The National Science 
Advisory Board for Biosecurity reported that there is little evidence that 
personnel reliability measures are effective or have predictive value in 
identifying individuals who may pose an insider risk. (4) Continuity of 
electrical power is vital for the safe functioning of high-containment 
laboratories, in particular since maintenance of essential pressure 
differentials using electrically driven fans provides an important barrier 
for preventing the uncontrolled release of agents.^ Lapses in electrical 
power that occurred at a CDC laboratory raise concerns about standards 
in high-containment laboratory facility design, management of 
construction, and operations. 


Pages 


GAO-09-1036T 



29 


Taken as a whole, these incidents demonstrate failures of systems and 
procedures meant to maintain biosafety in high-containment laboratories. 
For example, they revealed the failure to comply with regulatory 
requirements, safety measures that were not commensurate with the level 
of risk to public health posed by laboratory workers and pathogens in the 
laboratories, and the failure to fund ongoing facility maintenance and 
monitor the operational effectiveness of laboratory physical infrastructure. 


Conclusions 


Oversi^t plays a critical role in improving biosafety and ensuring that 
high-containment laboratories comply with regulations. However, some 
aspects of the current oversight programs provided by the Departments of 
Health and Human Services and Agriculture are dependent upon entities 
monitoring themselves and reporting incidents to federal regulators. Since 
2001, personnel reliability programs have been established to counter 
insider risks, but their cost, effectiveness, and programmatic impact have 
not been evaluated. 

In conclusion, proliferation of high-containment laboratories is taking 
place in all sectors. FXirthermore, since no single agency is in charge of the 
current expansion, no one is determining the associated aggregate risks 
posed by the expansion. As a consequence, no federal agency can 
determine whether high-containment laboratory capacity may now be less 
than, meet, or exceed the national need or is at a level that can be 
operated safely. 

If an agency was tasked or a mechanism was established with the purpose 
of overseeing the expansion of high-containment laboratories, it could 
develop a strategic plan to (1) ensure that the number and capabilities of 
potentially dangerous high-containment laboratories are no greater or less 
than necessary, (2) balance the risks and benefits of expanding such 
laboratories, and (3) determine the type of oversight needed. 

Such an agency or mechanism could anal 3 ^e the biothreat problems that 
need to be addressed by additional BSL-3 and -4 laboratories, the scientific 
and technical capabilities and containment features that such laboratories 
need to have, how the laboratories should be distributed geographically, 
and how the activities of the laboratories would be coordinated to achieve 
intended goals. The agency or mechanism responsible for overseeing the 
expansion of high-contairunent laboratories could also be responsible for 
coordinating with the scientific community to develop guidelines for high- 
containment laboratory design, construction, and commissioning and 
training standards for laboratory workers; providing definitions for 


GAO-09-1036T 



30 


exposure; developing appropriate inventory control measures; and 
providing guidance on tiie most efficient approach to personnel reliabOity 
programs. 

Overall, the safety record of high-containment laboratories has been good, 
although a number of weaknesses have become apparent over time. 
Consequently, along with expansion there needs to be a commensurate 
development of both operational and oversight procedures to address 
known deficiencies and, as far as practicable, proactively evaluate future 
risks. 

Laboratoiy operators, in collaboration with regulators, need to develop 
and work through potential failure scenarios and use that information to 
develop and put in place mechanisms to challenge procedures, systems, 
and equipment to ensure continuing effectiveness. 


R6C0niinGnd3.ti0nS for address these issues, we recommended that the National Security 
Advisor, in consultation with the Secretaries of Health and Human 
Executive Action services (HHS), Agriculture, Defense (DOD), and Homeland Security 

(DHS); the National Intelligence Council; and other executive departments 
as deemed appropriate identify a single entity charged with periodic 
govemmentwide strategic evaluation of high-containment laboratories 
that will 

(1) determine 

• the number, locations, and mission of the laboratories needed to 
effectively meet national goals to counter biothreats, 

• the existing capacity within the United States, 

• the aggregate risks associated with the laboratories' expansion, and 

• the type of oversight needed, and 

(2) develop, in consultation with the scientific community, national 
standards for the design, construction, commissioning, and operation of 
high-containment laboratories, specifically including provisions for long- 
term maintenance. 

We recommended that the Secretaries of HHS and USDA develop (1) a 
clear definition of exposure to select agents and (2) a mechanism for 
sharing lessons learned from reported laboratory accidents so that best 
practices — for other operators of high-containment laboratories — can be 
identified. 


Page 5 


GAO-09-1036T 



31 




Should the Secretaries consider implementing a personnel reliability 
program for high-containment laboratories to deal with insider risk, we 
recommended that they evaluate and document the cost, effectiveness, 
and programmatic impact of such a program. 


Recognizing that biological agent inventories cannot be completely 
controlled at present, we also recommended that the Secretaries of HHS 
and USDA review existing inventory control systems and invest in and 
develop appropriate technologies to minimize the potential for insider 
misuse of biological agents. 

Agency Comments 
and Our Evaluations 

We obtained written comments on a draft of our report from the 

Secretaries of HHS and USDA. The Executive Office of the President: 
National Security Council did not provide comments. HHS and USDA 
concurred with our recommendations that were direcled to them. 

Mr. Chairman, this concludes my prepared remarks. I would be happy to 
respond to any questions that you or other members of the subcommittee 
may have at this time. 

Contact and 
Acknowledgments 

If you or your staffs have any questions about this report, please contact 
me at (202) 512-2700 or kingsburyn@gao.gov or Sushil K. Sharma, Ph.D., 
Dr.PH, at (202) 512-3460 or shannasC^gao.gov. Contact points for our 
Offices of Congressional Relations and Public Affairs may be found on the 
last page of this statement. Amy Bowser, George Depaoli, Terrell Dorn, 

Jeff McDermott, Jean McSween, Jack Melling, Ph.D., Corey Scherrer, 

Linda Sellevaag, and Elaine Vaurio made key contributions to this 
testimony. 


(460607) 


GAO-09-1036T 




32 


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33 


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34 


Mr. Stupak. Dr. Atlas, opening statement, please, sir. 

STATEMENT OF RONALD M. ATLAS, Ph.D. 

Mr. Atlas. Thank you, Mr. Chairman, members of the sub- 
committee. I want to thank you for the opportunity to testify on be- 
half of the American Society for Microbiology. 

When I began my career 40 years ago, we thought we had con- 
quered infectious diseases, but in fact that is not the case. We have 
newly emerging infectious diseases every year, whether it is SARS 
or multidrug and extremely drug-resistant tuberculosis or the re- 
current outbreak of the HlNl influenza. And these outbreaks of 
disease have not only public health but also economic and political 
repercussions, and therefore we need to carry out research to find 
the therapeutic vaccines, diagnostics and other ways of coping with 
these diseases. 

In other words, we must continue to perform research on patho- 
genic microorganisms, and much of that research needs to be per- 
formed in high-containment laboratories where the safety of the 
scientists working on the organisms, as well as the public, can be 
protected. These are not weapons laboratories; rather, they are re- 
search laboratories where investigations are carried out with the 
aim of protecting public health. 

Inevitably, as we have seen in the tragic case in Chicago, at least 
from the reports, there is risk to the scientists and perhaps to the 
community when we work with these organisms. And accordingly, 
the American Society for Microbiology has strongly supported re- 
sponsible regulation, oversight, practices and guidelines that im- 
prove laboratory biosafety and protect laboratory personnel, the 
public and the efficacious performance of the research that leads to 
vaccines, therapeutic drugs and diagnostics that we need. And over 
the years we have reached a balance, at least for the moment, be- 
tween the safety practices that are carried out in the laboratory 
and the ability to perform research. 

Although these procedures, when properly followed, do provide a 
level of safety to the workers in the community, the ASM feels that 
we continuously need to review these practices and to find new and 
better ways to move forward. 

During the past 2 years, the ASM has met with the Trans-Fed- 
eral Task Force on Biosafety and Biocontainment Oversight and 
the Executive Order Working Group on strengthening the biosecu- 
rity of the United States and made a number of recommendations 
to those groups. Clearly, there is a need to ensure adequate train- 
ing and strict compliance to provide the levels of protection engen- 
dered in existing biosafety procedures, as well as those that may 
be proposed. 

The ASM has made a number of recommendations which I would 
like to summarize for you. 

First, the Biosafety and Microbiological and Biomedical Labora- 
tories Manual, or the BMBL, which contains the core guidelines for 
the safe operation of all microbiological laboratories, should be the 
subject of regular biennial review and update, as needed. The 
BMBL, along with the NIH guidelines for recombinant DNA re- 
search, are essential reference documents. We need to continuously 
examine these, update them, and provide more guidance for the 



35 


community and to develop specific competencies for biosafety train- 
ing and recommended procedures for incident reporting. The ASM 
view is that the CDC, NIH, and USDA should take the lead for 
BMBL revisions, but there should be input through from the com- 
munity. 

Second, the list of pathogens designated as select agents and 
those requiring BSL-3 and BSL-4 containment should be regularly 
updated; and again, we would urge that a scientific community 
that is broadly based help to guide the development of these lists. 

Third, there should be mandated training and performance re- 
quirements for biosafety personnel overseeing the safety of high- 
containment laboratories. And again, the NIH and CDC should 
make educational training programs available, and we should con- 
tinuously look to the standards that need to be achieved. 

Fourth, the select agent regulation should be revised to change 
the requirements for inventory of vials and select agents. Labora- 
tories should be accountable for which agents they possess and 
where these agents are located, but counting of vials that are in 
a freezer when we are dealing with live organisms provides a false 
sense of security and does not really help in protecting the Nation. 

Fifth, the NIH requirements that foreign institutions must have 
comparable facilities and standards that are U.S. Collaborative 
should be changed to remove hurdles for international collabora- 
tion. We have been struck by the UTMB experience where they no 
longer can get strains of hemorrhagic fever viruses into the United 
States because the laboratories overseas that, in fact, are holding 
those organisms may not meet U.S. standards. 

Six, the Congress should enhance funding, as needed, to ensure 
the upkeep of the high-containment laboratories. Now that many 
of these laboratories have been constructed, they should be con- 
cerned that they continue to meet the high standards to which they 
were built. 

Seven, we need an improved system for surveillance and report- 
ing of laboratory-acquired illnesses. This should be done in a way 
where we learn lessons from incidents which, unfortunately, occur 
rather than trying to hide these incidents for fear of recrimination. 

And finally, we should be examining very carefully the costs and 
benefits of potential accreditation systems. In this regard, we see 
the current select agent regulations as providing a 
pseudoaccreditation. There are standards, there are inspections; as 
has been pointed out, this does not exist for the nonselect agents, 
and I think we need to examine the potential value of moving for- 
ward. 

We would note that the American Biological Safety Organization, 
ABSA, is in fact in the process of developing a voluntary accredita- 
tion system. I think we need to look at that. But moreover, we real- 
ly need to develop the standards and look to what we need to hold 
the labs accountable for and have a system in place where we can 
assure this committee and the Nation that we are complying. 

In conclusion, I think we have made tremendous strides over the 
past years in moving towards meeting the needs of the Nation both 
in terms of the research and the safety. More needs to be done. We 
need to do this carefully and in a considerate way, so we don’t 
upset an apple cart and put the Nation at risk. 



36 


Thank you, Mr. Chairman, and I look forward to your questions. 
[The prepared statement of Mr. Atlas follows:] 



37 


AMERICAN 
SOCIETY FOR 

MICROBIOLOGY Public and Scientific Affairs Board 

American Society for Microbiology's testimony before the Committee on Energy 
and Commerce Subcommittee on Oversight and Investigations on 
Federal Oversight of High Containment Bio-Laboratories 
September 22, 2009 

The American Society for Microbiology (ASM) is pleased to testify before the House Energy 
and Commerce Committee Subcommittee on Oversight and Investigations hearing on Federal 
Oversight of High Containment Biolaboratories. 

My name is Ronald Atlas and I am CoChair of the ASM Public and Scientific Affairs Board 
Committee on Biodefense and a Past President of the ASM. I am also Professor of Biology at the 
University of Louisville. The ASM is the largest single life science Society in the world with a 
membership of about 40,000 scientists and health professionals. ASM members are involved in 
basic and applied research, clinical laboratory testing and public health activities that are focused 
on developing new preventions, therapies and cures for infectious diseases. To meet the 
challenges of emerging and reemerging infectious diseases, microbiologists work in laboratories 
in which highly pathogenic agents are stored and studied. The ASM is interested in assuring that 
such agents are maintained in a manner that is safe for laboratory personnel and the public. 

Infectious diseases remain among the most difficult global health challenges accounting for 
about one quarter of all deaths. Newly recognized infectious diseases occur almost yearly, as 
evidenced by influenza A (HlNl), avian influenza (H5N1), multidrug and extensively drug 
resistant agents (MDRTB/XDRTB), and severe acute respiratory syndrome (SARS), just in the 
last decade alone. These episodes have public health as well as economic and political 
repercussions. It is critical that scientists in the public and private sectors and health 
professionals have appropriate facilities and laboratories for the development of new therapies, 
diagnostics, and prevention and detection methods aimed at reducing the risk of infectious 
diseases. For example, it is essential that investigators in industry and academia have the proper 
facilities to work on these infectious agents to develop new vaccines and drugs for which in 
some cases there are few to no existing therapies. Today 30-40 percent of XDRTB strains are 
unbeatable with existing drugs and these strains are becoming more common and widespread. 

An HlNl vaccine could not have been rapidly or safely developed without existing research 
laboratory infrastructure. 



1 



38 


Research on pathogenic microorganisms, which is critical for the health and security of the 
public and the nation, must be performed safely. Accordingly, the ASM has consistently 
supported responsible regulation, oversight, practices and guidelines that improve biosafety in 
laboratories and help to protect laboratory personnel, the safety of the surrounding communities, 
and the efficacious performance of the research that leads to the vaccines, therapeutic drugs, 
diagnostics, and other measures that are so needed today to protect the public against the plethora 
of infectious diseases that occur in the United States and globally. 

During the past two years, the ASM has met with and provided recommendations to the Trans 
Federal Task Force on Biosafety and Biocontainment Oversight and the Executive Order Work 
Group on Strengthening the Biosecurity of the United States. We understand that these groups 
have undertaken extensive consultation with the public health and research community and that 
they will soon release reports and recommendations regarding biosafety and biosecurity. We 
recommend careful consideration of their recommendations, as well as a thoughtful and 
deliberate approach to any additional or new requirements for biosafety and biosecurity in 
laboratories. It took a number of years and substantial effort to arrive at the careful equilibrium 
that currently exists to oversee and manage research activities. We believe that precipitous, 
excessive policy changes could upset this delicate balance and, therefore, should be considered 
in the context of the critical need to conduct public health activities, clinical diagnostic testing 
and research on pathogens that will lead to new and improved vaccines, therapeutics, diagnostics 
and other measures to protect against infectious diseases, whether naturally occurring or the 
result of an intentional act. 

The ASM would like to comment on 1) the need for biocontainment laboratories, 2) the select 
agent regulations, 3) the importance of biosafety for laboratories and laboratory personnel and 4) 
recommendations to improve biosafety. A number of our recommendations continue to reflect 
those we made to the Subcommittee in 2007 and subsequently to the federal agency groups 
addressing biosafety, biocontainment and biosecurity. 

1) The Need for Biocontainment Laboratories High containment laboratories should be 
constructed and maintained to ensure the safety of the laboratory workers and the broader 
community. Newly emerging and reemerging infectious diseases are appearing at the same time 
that microbial resistance to standard therapeutics is on the increase. This lethal combination of 
events presents enormous challenges to public health. In an age of extensive international air 
travel and commerce, infectious diseases have become a security issue for every nation on the 
globe, including the United States. Despite the best efforts of goverrunent agencies, the public 
may be at risk for exposure not only to infectious diseases arising within the United States but 
also at risk to infectious diseases outside our borders. 


2 



39 


Over the past thirty years, public health agencies have confronted a myriad of infectious 
diseases, such as pandemic influenza, HIV/AIDS, extensively drug resistant tuberculosis (XDR 
TB), SARS, tnelhicillin resistant Staphylococcus aureus (MRSA) Ebola hemorrhagic fever, 

Lyme disease, toxic shock syndrome. Legionnaires’ disease, hantavirus pulmonary syndrome. 
West Nile fever, and others. According to the CDC, 75 percent of these emerging and 
reemerging infectious diseases, including SARS, hantavirus pulmonary syndrome, Nipah virus 
encephalitis, influenza, and West Nile fever, are zoonotic, which means that they are transmitted 
from animals to humans. Although terrible to contemplate, we must also confront the possibility 
of misuse of science. As the scientific community responds to emerging, reemerging, and drug 
resistant diseases, it also must prepare to deal with the possibility of an intentional misuse of 
science for the creation, or spread, of infectious diseases. 

Public health and safety depends upon skilled and highly trained microbiologists and other 
health professionals to make every effort to find methods to prevent, diagnose, and treat 
infectious diseases and to respond rapidly to emerging and reemerging diseases and threat of 
bioterrorism. To meet these challenges, scientists and public health professionals must have 
laboratories in which pathogens may be stored and studied in a manner that is safe for 
microbiologists and to the community-at-large. 

Congress recognized the seriousness of the threat of bioterrorism in the aftennath of the 2001 
anthrax crime and increased appropriations for biodefense research. In early 2002, the National 
Institute of Allergy and Infectious Diseases (NIAID) convened a panel of experts, the Blue 
Ribbon Panel on Bioterrorism and its Implications for Biomedical Research. This Panel provided 
guidance on the future biodefense and emerging diseases research agenda, research resources, 
facilities and scientific personnel. The capacity of existing biocontaimnent facilities were 
determined to be inadequate to meet needs for biodefense and emerging diseases work. New 
facilities at BSL 3 and 4 levels of containment needed to be constructed .so that the necessary 
research to protect the nation could be conducted safely and to provide surge diagnostic capacity 
in the event of a biotenrorism attack or a pandemic disease outbreak. The NIAID has funded 2 
National Biocontainment Laboratories and 13 Regional Bioconlainmcnt Laboratories to provide 
safe and secure space for biodefense and emerging diseases research. These laboratories help 
support the network of 10 nationwide muUidisciplinary Regional Centers for Excellence for 
Biodefense and Emerging Infectious Diseases Research that Ihe NIAID has established to meet 
the growing challenge of infectious diseases and to combat the threat of bioterrorism. 

The establishment of new biocontainment laboratories has been done openly and under the 
scrutiny of local municipalities and a federal regulatory and oversight system. They have been 
constructed in accordance with environmental impact assessments and other applicable standards 
for biosafety. The new BSL3 and BSL4 laboratories constructed with funds provided in part by 


3 



40 


the National Institutes of Health (NIH) have been subject to rigorous oversight by NM'NIAID 
program staff throughout all phases of design and construction. They are a critical resource in the 
nation’s response to the public health issues posed by emerging and reemerging infectious 
diseases. 

2) Select Agent Regulations The select agent regulations already provide mandatory oversight 
of biosafety and biosecurity for laboratories working with these agents, including all private as 
well as public laboratories. These laboratories are subject to federal laws, regulations and 
policies which seek to ensure a safe and secure environment in which to conduct research on 
dangerous pathogens and toxins. They must follow biosafety procedures to protect personnel 
working in the laboratory and the outside community. The select agent regulations specify 
reporting requirements for any significant problems, violations, or any research related accidents 
and illnesses. Institutions are also required to comply with the CDC and US Department of 
Agriculture APHIS Select Agent regulations if they possess, use, or transfer select agents and 
toxins that have been determined to have the potential to pose a severe threat to public health and 
safety. These regulations mandate an FBI security risk assessment for individuals authorized to 
have access to select agents, incident response plans, and a security and safety plan to safeguard 
the select agents (42 CFR Part 73, 7 CFR Part 331 and 9 CFR Part 121). The ASM recommends 
regular review of the select agent regulations. This review should involve the broad scientific 
community. As needed the lists of agents and the requirements of the regulations should be 
modified to ensure appropriate biosecurity and biosafety. 

The ASM has consistently supported the leadership role of the Department of Health and Human 
Services (HHS), the Centers for Disease Control and Prevention (CDC) and the US Department 
of Agriculture Animal Plant Health Inspection Service (APHIS) in administering the select agent 
and toxin regulations for facilities that possess, use or transfer select agents and toxins. The 
HHS, CDC and APHIS are experienced and knowledgeable about infectious diseases involving 
select agents and toxins. The HHS, CDC and APHIS are committed to the protection of public 
health and safety. We recommend that any changes needed to improve biosafety and to ensure 
biosecurify in laboratories build upon existing HHS and USDA programs, including the Select 
Agent program, rather than through new statutoiy programs. We continue to support locating the 
Select Agent Program at the HHS/CDC for human and overlap agents and at the USDA/APHIS 
for animal and plant pathogens because these agencies have the appropriate public health 
expertise, laboratory experience in the life sciences and oversight capacity for biosafety and 
biosecurity. 

3) The Importance of Biosafety Requirements for Microbiology Laboratories and 
Personnel The Biosafety in Microbiological and Biomedical Laboratories (BMBL) must set the 
standards for the safe handling of infectious agents in the laboratoiy and best practices to ensure 


4 



41 


biosafety. Laboratories with capacity at BSL3 and BSL4 are designed to maximize the safety of 
laboratory staff and minimize the potential that a pathogen could escape. 

There is already extensive government guidance, oversight and regulation of activities involving 
microbes and toxins. The Biosafety in Microbiological and Biomedical Laboratories, BMBL, 

5th Edition, published by the CDC and NIH, describes microbiological practices, laboratory 
facilities and safety equipment for work with infectious agents. Through the BMBL, CDC and 
NIH have set standard procedures to be followed when working with infectious agents. There are 
also additional guidelines that come from other documents. The shipment of infectious agents is 
regulated by the DOT, Department of Commerce, CDC and USDA. Bloodbome pathogens are 
regulated by OSHA. The NIH Guidelines for Research Involving Recombinant DNA Molecules 
establish safety guidelines for research with recombinant DNA,including recombinant DNA 
research with infectious agents. They require institutions receiving NIH funding to have 
Biosafety Officers and Institutional Biosafety Committees (IBCs). The NIH Office of 
Biotechnology Activities provides resources and training on the role and responsibilities of IBCs, 
which examine research protocols, expertise, potential hazards and containment plans. Many 
institutions assign IBCs broader responsibility for overseeing research with nonrecombinant 
infectious agents. 

4) Recommendations to Improve the BMBL, Lists of pathogens, Training, Oversight, 
Inventory, International exchange. Transportation, Resources, Reporting and 
Accreditation Although there are procedures in place for providing biosafety if properly 
followed, there is an ongoing need to review and enhance biosafety. In this regard, there is a 
need to ensure adequate training and strict compliance to provide the levels of protection 
engendered in those procedures. Laboratory workers who handle infectious pathogens are at 
potential risk of acquiring an infection. Therefore, adequate training in microbiological practices 
and biosafety is essential to working safely with hazardous biological agents, and protecting the 
public health. Exposure and risk may be prevented or minimized by rigorous implementation of 
appropriate laboratory practices and containment, safety equipment, improvement and 
maintenance of facilities, and formal, validated training of technical, support and administrative 
personnel. Laboratory risk assessment is very important because it enables the selection of the 
appropriate microbiological practices, safety equipment and facility safeguards for research and 
testing. 

With these considerations in mind, ASM makes the following recommendations: 

Biosafety in Microbiological and Biomedical Laboratories Manual (BMBL: The BMBL 
should be subject to regular biennial review and update as needed. More guidance is needed on 
specific competencies for biosafety training and recommended procedures for incident reporting. 


5 



42 


The CDC, NIH and USDA should take the lead for BMBL revisions and for maintaining the 
currency of the list of organisms requiring containment. There should be a broad advisory 
committee that includes representation from the relevant scientific and biosafety organizations. 
The BMBL should be published in hard copy and made widely available, with aggressive 
communication to all involved parties for use as a reference for biosafety. It is important to 
establish the rules for biosafety and then accumulate suggestions for modifications based on 
experience and evolving scientific knowledge. Compliance with the BMBL biosafety and 
biosecurity standards should be a term of award by all federal agencies and there should be 
assurance that institutions are adhering to the BMBL. 

Lists of Pathogens: Lists of pathogens designated as select agents and those requiring BSL 3 
and 4 containment should be regularly updated. The CDC, NIH and USDA should review and 
update the BMBL list of agents biennially as is required and more often as needed. A scientific 
advisory committee to help guide which organisms are included should be established. There is 
also need to harmonize internationally the appropriate levels of containment for pathogenic 
microorganisms. 

Training; There should be mandatory, periodic training for all personnel working in BSL3 and 
BSL4 laboratories. Learning competencies should be established for biosafety training and 
formal training programs should be required and documented. The training that laboratory 
personnel receive should be validated to ensure the adequacy of biosafety knowledge. Not only 
should laboratoiy personnel be properly trained, but also those who are responsible for facility 
operations, equipment and management should receive appropriate training. This training is 
needed to ensure that all personnel in laboratories where w'ork with biohazardous are competence 
to work at a level that provides for their own safety and that of the community. 

The NIH Regional Centers of Excellence serve an important role for training and exchange of 
information about biosafety practices. Their role should be encouraged and enhanced. As these 
Centers develop it will be important to learn from experience, share information, and implement 
improved procedures to protect the safety of workers and the wider community. 

Oversight; There should be mandated training and performance requirements for biosafety 
personnel overseeing the safety of high containment laboratories. The NIH and CDC should 
make educational and training programs available. Oversight of biosafety at multiple levels is 
essential. Harmonized integrated systems of oversight of all pathogens are needed. Institutional 
Biosafety Committees, Biosafety Officers and Laboratory Directors, which evaluate risk and 
safety issues at the local level, as well as the institutionally designated Select Agent Responsible 
Officials, should ensure instimtional adherence to the BMBL, the NIH Guidelines, and other 
applicable regulations for laboratory safety and security. 


6 



43 


The CDC and NIH should ensure that good communication channels are in place for biosafety 
persoimel to assist them in making informed decisions about risk management. The NIH and the 
CDC should consider further guidance and outreach activities for biosafety persoimel to assist 
them in regulatory interpretation and containment for research on highly infectious agents and 
new scientific techniques, where guidance and uniformity of risk information may not be well 
established. Biosafety personnel should work closely with researchers in containment settings to 
review and improve safety procedures that protect public health. The occupational health clinic 
(or other medical oversight) is also an important part of open communications between those 
laboratory workers and the biosafety officers. 

The NIH should ensure that biosafety personnel have a clear understanding of the circumstances 
for consulting with the NIH Office of Biotechnology Activities on research containment and 
regulatory issues. The BMBL and the NIH Guidelines are essential reference documents for 
biosafety practice and oversight and should be required for institutions conducting research. The 
CDC and NIH should work with research institutions, and the scientific and biosafety 
communities to ensure that current biosafety guidelines, regulations for biosafety and biosecurity 
are well understood, appropriate and implemented to ensure safe laboratory procedures. 
Understanding and adhering to biosafety principles and practices, risk assessment, appropriate 
containment and facility safeguards will contribute to safe laboratories, research and testing. 

Inventory: The select agent regulations should be revised to change the requirements for 
inventory of vials of select agents. Given the intrinsic biological properties of microbes, the 
actual counting of vials is meaningless, ineffective, misleading and should not be required. 

Rather laboratories should be accountable for which agents they possess and where these agents 
are located. 

International Exchange; The NIH requirements that foreign institutions must have comparable 
facilities and standards to their US collaborators should be changed to remove hurdles for 
international collaboration. The current requirements are impeding collaborative research on 
infectious diseases and making it difficult to share reagents, antigens and to exchange biological 
samples and specimens. Many of the agents of concern only produce disease outside the United 
States and studies involving them require that we have a robust and fruitful scientific exchange 
with international colleagues. It is critical to maintain collaboration with foreign researchers on 
science and public health, particularly on infectious diseases where extensive work is done 
internationally. It is vital to ensure the open flow' of biological samples into the United States and 
the shipment of samples abroad. 


7 



44 


Transportation: A single web site with up to date information on how infectious agents should 
be transported should be created. Distribution of microorganisms for identification, research, 
reference production, and diagnostic purposes is essential to public health and scientific progress. 
Safe handling that minimizes risk is essential. Effective communication from regulators such at 
DOT, Department of Commerce, and USDA will aid compliance with regulations. 

Resources; The Congress should enhance funding, as needed, to ensure the upkeep of high 
containment laboratories are met and that there are adequate funds for biosafety needs, including 
personnel training. Biocontainment laboratories are expensive and a large investment, not only in 
the cost of construction, but in the cost of operations, maintenance, training, oversight and 
community relations. The design and building of biocontainment facilities requires careful 
guidance from funding agencies, the development of useful standards for biosafety experts and 
managers to ensure effective biosafety, oversight and inspection over the life-cycle of the 
laboratory. Facilities must ensure that maintenance and renovations do not result in breeches of 
containment. 

The needs for additional support for biosafety oversight and maintenance of biocontainment 
laboratories should be evaluated to ensure there is adequate institutional, agency and community 
support. It is important that the investments made to date by the government in these laboratories 
be sustained to ensure their continued safe operation. 

Reporting; An improved surveillance and reporting of laboratory acquired illness and response 
should be established, even for those incidents not covered by the Select Agent regulations. 

There should be a reporting requirement for illnesses suspected of being laboratory acquired. 
Incidents of laboratory acquired infections have been documented in the United States. 

Notifiable infectious diseases must now be reported to local and/or state public health agencies to 
enable assessment of risk and response and to alert physicians and the public to take appropriate 
steps, if necessary. However, data on whether the infection occurred in a laboratory is not 
routinely collected for many reportable diseases. CDC and Jocal/state public health authorities 
should w'ork with institutions, investigators and biosafety personnel to analyze occurrences of 
laboratory acquired illnesses and to provide reports and information in a way that will help 
reduce the risk and reoccurrence of any incidents. Improved reporting of laboratory acquired 
illness, investigation and response would provide valuable lessons for maintaining safe 
conditions in research and clinical laboratories. To prioritize interventions and to determine the 
effectiveness of those inventions. 

Accreditation: Accreditation of high containment laboratories may be desirable and the costs 
and benefits should be carefully explored. Any accreditation of laboratories should be well 
defined and standards would need to be established before such a program is undertaken. The 


8 



45 


select agent regulations already require facilities to be registered, to undergo a safety and 
security risk assessment, to clear personnel with access to select agents and to be inspected. The 
scientific community is greatly concerned about issues surrounding laboratory accreditation and 
should be fully engaged and consulted during federal decision making on standards, guidelines, 
and the process for any accreditation program. A formal assessment should be undertaken to 
evaluate the costs, benefits and efficacy of registering and/or accrediting high containment 
laboratories. The study should address; which high containment laboratories, if any, should be 
registered and or accredited; who should be responsible for registration and or accreditation and 
what should be the budgetary considerations and how costs associated with accreditation should 
be covered. 

In conclusion, the laboratory infrastructure in the United States has made tremendous strides in 
the past decade to meet the challenges of emerging diseases and biothreats. This progress is 
based on the careful balance of research needs and regulatory oversight. Any changes to the 
current system should be carefully considered and crafted to ensure this delicate balance is not 
upset and impedes research and countermeasures development. These changes should also be 
considered with input from the scientific and public health community. We should take steps to 
enhance biosafety and assure biosecurity of high containment laboratories by increasing 
awareness within the scientific community, improving federal government guidance, establishing 
standards for biosafety and, carefully evaluating moving toward a defined accreditation system. 
To enhance biosafety we need to build on the culture of responsibility across the scientific 
community and enhance a culture that embraces the premise that the misuse of science is 
absolutely wrong and that good laboratory practices should be required. Awareness and 
education are the most critical components. The ASM would be pleased to work with Congress 
and the oversight agencies to accomplish these tasks. 


9 



46 


Mr. Stupak. Thank you both for your testimony. 

One of the things we have learned from the oversight hearings 
is that there is no Federal agency in charge of the expansion of the 
high-containment labs. I think the average citizen would be sur- 
prised to learn that the government doesn’t even know how many 
BSL-3 labs there are in the United States. 

On Table 3 from the GAO report — you might want to put it up 
on the monitor — we see that the number of BSL-4 labs has in- 
creased even since 2007 when we held our first hearing. There are 
now two more BLS-4 labs that are fully operational in the United 
States since our 2007 hearing. There are also seven more BSL-4 
labs currently under construction. 

So if we go back and we look at your Figure 1 in the GAO report 
and Figure 1 on our monitor, we can see locations of the BSL-4 
labs are being built right now across the United States. When 
these labs become operational, we will have double the BSL-4 ca- 
pacity in the United States without any Federal agency analyzing 
whether this is appropriate needs for our country. 

And if we look at Figure 2 in the GAO report, we can see that 
the number of BSL-3 labs has continued to increase in the same 
period of time. Table 4 shows there are about 1,400 BSL-3 labs in 
the United States, and these are only the BSL-3 labs registered 
with the Federal Government. We can only guess how many there 
are out there, because they don’t have to register unless it is han- 
dling one of those agents. 

Do you have any concerns about the increase we have seen in the 
number of high-containment labs? 

Ms. Kingsbury. Yes, sir. 

Mr. Stupak. Could you explain your concerns. 

Ms. Kingsbury. Well, the concern is, there may be a need for 
this number of laboratories, but nobody is looking at the total pic- 
ture. Nobody is looking at what the public health and public safety 
research needs are, and linking that to where labs are built and 
how many of them we need. And if you look at the combination of 
Table 4 and Table 5, which are the labs that are registered with 
APHIS at the Department of Agriculture, you end up with more 
than 1,600 BSL-3 labs out there. That just seems like a lot. 

Mr. Stupak. You mentioned the Department of Agriculture, and 
Dr. Atlas, in your report and letter that you sent after our last 
hearing — were you the author of that letter or was there a team 
that did that? 

Mr. Atlas. We have a team. 

Mr. Stupak. — you mention about — because of APHIS and the De- 
partment of Ag there, because 75 percent of the new infectious dis- 
ease we are seeing actually comes from animals passed to humans; 
is that correct? 

Mr. Atlas. That is correct. 

Mr. Stupak. Dr. Atlas, do you have any concerns about this in- 
creased number of labs we are seeing? 

Mr. Atlas. I don’t think I have the same sort of concern that is 
expressed in the GAO report because I see these labs as safe labs. 
If you tell me that we are creating more safe infrastructure within 
the Nation, where research can be performed, that is something 
that I support. 



47 


So from that sense, no, I don’t have the same concern in terms 
of safety when you tell me it is a safer laboratory structure. 

Now, is it more safe than we need? I guess I don’t see things that 
way. 

Mr. Stupak. Let me ask you this question. In your October 4th 
letter, and it was updated in July of this year for this hearing, on 
the second page it says, “Facilities at BSL-3 and -4 levels of con- 
tainment have been constructed because the number and capacity 
of existing biocontainment facilities were determined to be inad- 
equate to meet the needs for biodefense and emerging disease 
work.” 

What is the right number then? What is the right number we 
need of Level 3 and Level 4 labs? 

Mr. Atlas. I don’t know the right number overall. Certainly 
there was an assessment done at the National Institutes of Health 
that suggested we needed something on the order of 10 to 15 re- 
gional laboratories to cover the Nation that would provide core re- 
sources for the research and potential surge capacity if we had a 
major outbreak. 

Beyond that, a number of institutions have seen the need or de- 
sirability to have small laboratories where they could do research 
on agents in a safe manner. 

Mr. Stupak. My concern is — and I think Dr. Kingsbury pointed 
out — unlike, let’s say, nuclear material, with these agents, they are 
always growing, expanding. And in looking at the GAO report, and 
even your report or your testimony, one of these errors we have is 
human error and it just comes inherent with the job. And with nu- 
clear, we try to contain it, we try to have less people handling it, 
less chance of error. 

Doesn’t the same logic hold true here that the more labs you 
have, the more scientists and researchers you have handling this, 
the more likely a disaster, not just within the lab, but escaping out- 
side the labs? 

Mr. Atlas. Not if we have the appropriate safety standards, and 
I think that is where we would put our emphasis on increasing the 
training and the resources to ensure that all of the workers in the 
laboratory are performing safely. I think it is important 

Mr. Stupak. But there really is no safety. It is on-the-job train- 
ing, isn’t it? If I am a researcher, it is basically — I don’t go to some 
school to learn how to do it. 

Mr. Atlas. There are safety courses that are offered. 

Mr. Stupak. But not required. 

Mr. Atlas. They are not required, and therefore you are correct 
that much of the training is on the job. 

I think what the ASM would propose is that we, in fact, move 
to a system with national standards that would establish minimum 
guidelines for the training and that we provide the resources where 
we can assure this committee that anyone who is walking into a 
laboratory where dangerous agents are contained is adequately 
trained; and further, that we instill in the community a culture of 
responsibility with a zero tolerance for not following the proce- 
dures. 

Mr. Stupak. Sure. 



48 


Let me ask you this. If you go back to Figure No. 3 that we had 
up — it is in the GAO report. 

It is Figure No. 2 where you went from about 400 BSL labs in 
2004 to almost 1,400 in 2008. Can you find that chart? 

The question I want to ask — that is 2004, and we go up to almost 
1,400. Were these labs always in existence, and they never re- 
ported the select agents they are dealing with? I mean, how 

Mr. Atlas. That is probably true. What this graph represents is 
the number of laboratories, I believe, registered for work with se- 
lect agents. It does not necessarily represent the construction of 
new laboratories. 

Mr. Stupak. No; I know that. If I have a university, I may have 
many labs within my university structure. 

If you are supposed to be registered before, is there that much 
more interest in these 80 select agents; or have they always been 
doing the work, and we never knew about it? Which once again 
shows no coordination or no one is in charge here. 

Mr. Atlas. In post-2002, the Nation has made a significant in- 
vestment in bioterrorist-related or potentially related organisms. 
That has brought a great deal — as pointed out, we went from a 
very small budget to a $1.7 billion sort of investment in research 
that was largely in the research to be conducted rather than con- 
struction of new laboratories. And that has led to a number of indi- 
viduals joining in the effort to develop vaccines against Ebola and 
anthrax and the other diseases, to protect the Nation about what 
is now seen as a new threat from the misuse of biological weapons. 

Mr. Stupak. It is sort of like what Mr. Walden said: We put the 
money out there and suddenly everyone became BSL-3 labs that 
do research. They follow the money and not necessarily the threat? 

Mr. Walden. I didn’t say that. 

Mr. Stupak. I know you didn’t say that. I’m summarizing. 

It almost seems like if we throw money out there, suddenly we 
are all BSL-3 and BSL-4 labs. 

Mr. Atlas. Certainly, when I testified before the Congress in the 
2002 era, there was a perception that we had a tremendous threat 
facing us, and we had to combat that threat by racing to develop 
stockpiles of vaccines and therapeutics that could be moved across 
the Nation. 

We needed better vaccines; when we looked at some of the ones 
we had, we decided they weren’t safe enough. Smallpox vaccine 
that you and I once used, we weren’t going to give to our children; 
we wanted something safer than that. 

We called upon the National Institute of Allergy and Infectious 
Disease to move forward with that. And, in fact, it has been a tre- 
mendous investment, that has been brought forth with congres- 
sional support and fervor, because the Congress was very worried 
about this disease. The community has responded by trying to per- 
form the needed research, and that has led to an expansion. 

Mr. Stupak. Mr. Walden. 

Mr. Walden. Thank you, Mr. Chairman. 

I have the dubious honor of representing the area with the larg- 
est biological attack on U.S. soil. The Bhagwan Shree Rajneesh set 
up encampment in southern Wasco County outside the town of An- 
telope. They concocted a little mixture that they then spread in the 



49 


salad bars in the city and poisoned hundreds of people. It took the 
Federal Government more than a year to admit that it was actu- 
ally a biological attack, this Salmonella strain that they spread. 

So I take this issue real seriously and realize there is a threat 
that if the folks in that encampment could pull it off, it could hap- 
pen by a serious terrorist somewhere. 

Do you think there is still a pretty good threat against the coun- 
try? 

Mr. Atlas. We understand that there is a threat of criminal ac- 
tivity and terrorism and that we need to be vigilant. 

From the community’s perspective, we need to develop a true 
taboo against the use of biological weapons. It is a zero tolerance — 
nowhere, no-how, no one — which also suggests that the community 
must be your eyes and ears and that we need a system whereby 
the community can responsibly report any suspicious activities that 
might represent misuse, and that the community has zero toler- 
ance for a lack of adherence to biosafety procedures. 

Mr. Walden. So, Dr. Atlas, I think that is a very salient point. 

Is there such a system in place where scientists who observe 
something they believe to be inappropriate can effectively commu- 
nicate that to somebody who can do something about it, at least 
check? 

Mr. Atlas. I don’t think we have an adequate coordinated sys- 
tem of knowing who to call, other than your local FBI office, which 
may not have the ability to adequately understand the information. 

Certainly, the American Society for Microbiology has put forth 
and is putting forth every day to our members a code of ethics that 
calls upon them to only use the science for the betterment of hu- 
mankind and to report to appropriate authorities any potential 
misuse of the science. 

Mr. Walden. Dr. Kingsbury, I haven’t had a chance to thor- 
oughly go through your report, but did you look at those issues at 
the GAO? 

Ms. Kingsbury. The issues you are talking about, the outbreak 
in Oregon? 

Mr. Walden. No. I am sorry. I moved off that into what Dr. 
Atlas is suggesting, that there isn’t a really good reporting mecha- 
nism for scientists to feed in observances of misuse of some of these 
agents. 

Ms. Kingsbury. There is really not, in any of the programs that 
we see. 

Mr. Walden. Did you review that in the course of your investiga- 
tion, though, that issue? 

Mr. Sharma. We looked at it in context of the Department of De- 
fense and the Department of Energy, which do have a personnel re- 
liability program. Even in those highly intrusive programs, there is 
no mechanism whereby a coworker can report on his coworker. 

Mr. Walden. Do you make recommendations in your report 
about such a system? 

Mr. Sharma. We made a recommendation that the Secretary of 
HHS and Agriculture — if they decide to implement this as a way 
to mitigate the inside risk, that they should consider the cost and 
impact of this program. 



50 


Now, let me just say within the Department of Defense we talked 
to a number of scientists who are working in BSL-3 and BSL-4 
labs and they all unanimously said that a determined scientist, de- 
spite the intrusive nature of the PR people, as they are called, can 
easily take the material out. There is nothing there that can stop 
a determined scientist. 

Mr. Walden. So, in other words, there is nothing we can do to 
stop a mad scientist from taking the pathogens out and doing 
whatever they want to do with them. 

Ms. Kingsbury. We already have laws against doing what some 
people might do to harm people. 

Mr. Walden. Is there a way to do some presecurity clearance? 
I don’t want to bog down our whole research system. 

Ms. Kingsbury. That is what a personnel — a more stringent per- 
sonnel security program would probably require. There is a cost to 
that. And the whole basis for our concern about the growth in the 
number of laboratories is grounded in the fact that this Federal 
Government needs to make some hard choices about costs. 

So you can’t do that if you are not doing an evaluation of what 
things cost and what you are getting from them. 

Mr. Walden. And what the risk is. 

Ms. Kingsbury. What the risk is, exactly right. 

Mr. Walden. We have heard these four incidents and then the 
latest, which was actually the Level 2 lab. How many are there? 

If you had 1,600 labs — by the way, that doesn’t mean 1,600 sepa- 
rate buildings; is that right? As the chairman said, you have got 
multiple labs that are in the same center. 

Ms. Kingsbury. Can be, but nobody knows how many there are. 

Mr. Walden. Does each agency that has labs know how many 
labs that they have? Does HHS know how many labs they have? 
Does USDA know how many labs they have? 

Ms. Kingsbury. The Federal agencies probably do, yes. 

Mr. Walden. So somebody knows, silo by silo, agency by agency, 
what labs they have? 

Ms. Kingsbury. Which ones have been built by the Federal Gov- 
ernment. But these labs are being built by the State government, 
they are being built in the private sector, they are being built by 
other than the Federal 

Mr. Walden. If I wanted to go out and build a lab and deal with 
these agents at Level 3 or 4, can I do that and not tell anybody? 

Ms. Kingsbury. You can’t do it and not tell anybody if they are 
on the select agent list. 

If they are not on the select agent list, then, yes, you can. All 
you have to do is get the money for it. 

Mr. Walden. And the select agent list is the one that has the 
worst of the worst? 

Ms. Kingsbury. Most of the worst of the worst. 

Mr. Walden. So that raises the issue, should other agents be 
put — who gathers up the select agent list? 

Ms. Kingsbury. CDC and the Department of Agriculture, sepa- 
rately for human pathogens and plant and animal pathogens. 

Mr. Walden. All right. You said you thought there were too 
many labs at 1,600. 



51 


Ms. Kingsbury. We said we don’t know whether there are too 
many, whether there are too few. 

Mr. Walden. I thought you said earlier today that you thought 
there were too many. 

Ms. Kingsbury. I very carefully said, we need to find out how 
many are really out there, we need to look at the national strategy, 
the current consideration of the biothreat and decide whether that 
amount of capacity is less than we need, the same of what we 
need — and so we have got it right by guess — or more than what we 
need. 

And if I were a betting person, my bet would be on more. 

Mr. Walden. We have more labs than we need? 

Ms. Kingsbury. There is a very, very large capacity to do this 
kind of work, and without looking again at the threat, without 
looking again at how much we really need, in comparison, at least 
at the Federal level, to the other needs facing our Nation today, I 
think that is a very important analysis that should be done. 

Mr. Walden. But you haven’t done that analysis, so that would 
be a personal opinion? 

Ms. Kingsbury. It is our view that the analysis should be done. 
It would not be appropriate for GAO to do it. GAO would argue 
that the executive branch has the responsibility for doing that. 

Mr. Walden. And would it be helpful — I assume when these 
other reports come out or are finalized by the Obama administra- 
tion that you all will take a look at those before going forward. 

Ms. Kingsbury. We will be very interested in looking at them in 
the context of some of our other ongoing work. Or if this sub- 
committee would like to ask us to do that, we can do that as well. 

Mr. Walden. Wouldn’t that round out your report? 

Ms. Kingsbury. It might. 

Mr. Walden. Thank you. My time has expired. 

Mr. Stupak. Mr. Green for questions. 

Mr. Green. Thank you, Mr. Chairman. 

You and the ranking member asked some of the best questions. 
And why don’t we have some type of mandatory certification, 
whether it is filled by State government or private entity. 

Dr. Atlas, is there any reason you can think of of not having 
some registration between these Federal agencies that oversee it? 

Mr. Atlas. I think the only issue from the community is the 
question of overregulation. A registration per se without require- 
ments for performance doesn’t get you very far. When you begin to 
impose inspections and other performance requirements, the ques- 
tion is, are they really helping you in terms of improving safety or 
security or are they paperwork. 

Mr. Green. When you are talking about BSL-3 or BSL-4 lab 
regulation and inspected on an annual basis, it doesn’t seem like — 
and some standards, I would hope, whether they are State-owned 
or privately owned, they would have their own safety standards, it 
would be common between these companies and State governments 
or even the Federal government. 

Mr. Atlas. For the most part, I think that is true, and certainly 
when we are dealing with the select agents, there are regular and 
sometimes multiple inspections by different agencies. 



52 


And for those labs, going back to the earlier question, the govern- 
ment knows exactly where they are, they know which agents are 
there, they know their performance requirements, and they have 
copies of all of their manuals of operating procedures. 

It is the other naturally recurring agents, whether it be the cur- 
rent influenza virus that is circulating or SARS when it broke out, 
that that was put into a laboratory, where we are not seeing the 
same oversight that we see for the select agents. 

Mr. Green. And I agree with you we don’t want to stop the re- 
search because I agree with HlNl, that we couldn’t be on where 
we are at now in the development without lots of different folks 
looking at it and different not only government agencies but non- 
government. But it just seems like between the Department of Ag- 
riculture and NIH or FDA we could have a Memorandum of Under- 
standing so they would have the same standards and they would 
split up the requirements, that they would have common standards 
to the benefit of the labs. 

Mr. Atlas. To some extent there is certainly coordination be- 
tween agriculture and HHS on many of these issues. I think what 
the ASM has proposed is that we have a full study of cost and ben- 
efit of moving towards standards, figure out what those standards 
would be and then see whether or not it is appropriate to institute 
an accreditation system across all the high containment labs. We 
are not ready to sort of jump off the bridge and say “mandate that” 
until we understand the cost benefits and what we would be look- 
ing at, but we think that that sort of study and examination ought 
to be done and done now. 

We have made that recommendation before both the Executive 
Order Working Group and the Trans Federal Task Force. I don’t 
know whether or not that has been accepted and whether that will 
move forward. 

Mr. Green. Dr. Kingsbury, in your testimony you talked about 
the decreasing budgets particularly for the agencies. And yet with 
a proliferation of the number of BSL3 labs, the doubling the BSL4, 
and nearly increase of 1,400, are we not seeing these agencies re- 
spond because they don’t have the funds to develop this coordi- 
nated effort? 

Ms. Kingsbury. That is part of the issue I suspect. It is also be- 
hind our concern about if you are going to have this many labora- 
tories you really need to think ahead about how you are going to 
fund them from a maintenance perspective. So it is all tied up in 
the same thing. I think what agency officials that we met with told 
us about this issue of interagency coordination is no one agency 
currently believes that it has the authority to direct another agency 
to do anything about the labs it funds. And so each agency may 
know what they have, but nobody, and one of the reasons we di- 
rected some of our recommendations to the National Security 
Council and the National Intelligence Council is that it would take 
something at that level, at the White House level, to figure out 
what needs to be done to give a single entity sufficient authority 
to do the kinds of things we are talking about here. 

Mr. Green. So you don’t think you would need legislation, it 
could actually be done under current regulations? 



53 


Ms. Kingsbury. I am not sure whether we need legislation or not 
frankly. I am looking forward to these reports that we have been 
talking about because we have some expectation that that issue 
maybe taken up. 

Mr. Green. Thank you, Mr. Chairman. I am all out of time. 

Mr. Stupak. Mr. Gingrey, questions, please. 

Mr. Gingrey. Mr. Chairman, thank you and, Mr. Chairman, I 
apologize to our witnesses. Dr. Kingsbury and Dr. Atlas, for being 
late. I had a press conference, but I am glad I didn’t miss this. I 
know it is a very important hearing, Mr. Chairman, and I appre- 
ciate your holding it. 

Dr. Atlas, let me ask you this. You reference the need for careful 
consideration of recommendations regarding new requirements for 
biosafety and biosecurity in laboratories in light of the very careful 
equilibrium that currently exists to oversee and manage research 
activities, and you also state that excessive policy changes could 
upset the delicate balance. 

Dr. Atlas, what could be the impact on our scientific community 
if we were to pursue a policy, certain changes that did upset that 
delicate balance, what would be the consequences of that? 

Mr. Atlas. The consequence is that the Nation would be less 
safe. If we don’t carry out the research that we need on infectious 
disease, if we have scientists abandoning work on pathogens to 
work in other areas, then, in fact, we are not going to have the vac- 
cines we need. We are not going to have the therapeutic drugs, and 
we are going to see that we cannot contain outbreaks of disease. 
If you went to an extreme, you just wouldn’t have a vaccine for 
HlNl coming in a few weeks. 

So we need to ensure that we are not having a burden on the 
community that causes scientists to say, I am going to go work 
elsewhere. That is the call for careful evaluation. It is not a call 
for no regulation, no oversight. Quite the opposite. It is a call for 
carefully considered, appropriate regulation and oversight. What 
one doesn’t want is a knee-jerk reaction that says, oh, my God, we 
have to do something, let’s do it today without thinking through 
the consequences, but once you have broad input from the commu- 
nity with leadership of HHS and USDA, the ASM thinks we can 
move ahead and continuously improving the system and that we 
need to have that done on a regular basis. It is not a one-time af- 
fair. 

Mr. Gingrey. Dr. Atlas, thank you, and I appreciate it. I want 
to use my remaining time to also ask Dr. Kingsbury a very impor- 
tant question as well. To my knowledge. Dr. Kingsbury, two gov- 
ernment reports were recently completed that deal with the subject 
of strengthening oversight of biosecurity in the United States, one 
completed by the Executive Working Group and, in fact, sent to the 
President in July, the other I understand just completed by the 
Trans-Federal Task Force on Optimizing Biosafety and Biocontain- 
ment Oversight, which is chaired by HHS and USDA, as you know. 
Given the subject matter of these yet to be released reports, I am 
wondering whether you think this hearing might have been better 
served or could be better served with these reports available for us 
to consider? 



54 


Ms. Kingsbury. “Might” may be a good word, but we don’t sub- 
stitute our judgment for the committee chairmen about when they 
want to have a hearing. 

Mr. Gingrey. I am not really asking you to second guess the 
chairman. I am just asking you your opinion in regard to these re- 
ports. 

Ms. Kingsbury. I am here to report to our work, sir, not my per- 
sonal opinions. 

Mr. Gingrey. Thank you very much. I will ask Dr. Atlas the 
same question in my remaining time. 

Mr. Atlas. I think the answer is we would be happy to meet 
with your staff or your committee again once those reports are 
issued to continue our dialogue. 

Ms. Kingsbury. We just talked recently, a few minutes ago, 
about the possibility of the chairman asking us to look at those re- 
ports and give him our views. 

Mr. Gingrey. Certainly. Well, again let me just say I think it is 
important that we, Mr. Chairman, maybe I would suggest that you 
strongly consider having a hearing, another hearing once those re- 
ports are released in light of this hearing today, and with that, Mr. 
Chairman, I will yield back my time, and I thank both witnesses 
for their response. 

Mr. Stupak. Thanks, Mr. Gingrey. Mr. Burgess for questions, 
please. 

Mr. Burgess. Thank you, Mr. Chairman. I apologize for being 
late. 

Mr. Chairman, I guess the question may have already been 
asked to you and we can discuss this afterwards, I don’t under- 
stand why we don’t have someone from the Department of Home- 
land Security here on the panel. 

Now the Department of Homeland Security recently selected 
Kansas as the site for the new foot and mouth disease facility. Are 
level 4 labs, and I will ask this to both of our witnesses, are level 
4 labs appropriate for inland research diseases such as foot and 
mouth disease? Wouldn’t it have been better to hold the hearing 
before we held the vote? You don’t have to answer the second part. 

But is an inland facility appropriate for this monitoring and re- 
search on a very contagious illness? Because 40 percent, 45 percent 
of the Nation’s cattle traverse the State of Kansas at some time in 
their lives. 

Ms. Kingsbury. It was a very large number in a recent resolu- 
tion discussion in the House about that. We issued a report re- 
cently that looked at the question not asking our opinion per se 
about whether it is appropriate to put a facility on the mainland 
as opposed to an island, but rather looking at the evidence that the 
Department of Homeland Security put forth in making that deci- 
sion and concluding, as they clearly did conclude, that there is no 
risk of doing foot and mouth disease research on the mainland, or 
essentially no risk. Then the facility that is being talked about is 
going to do more than foot and mouth disease, but the thing that 
has continued to concern us is that. A, foot and mouth disease is 
the most infectious virus on the planet, and, B, the research on 
that requires research with a lot of very large animals. And so the 
whole design and operational structure of that facility on the main- 



55 


land where cows are in the neighborhood has not yet heen laid out 
in a way that we would conclude, and our experts would conclude, 
has demonstrated that it is safe to do foot and mouth disease re- 
search in particular in that facility. 

Mr. Burgess. When do you expect that we will have the avail- 
ahility of that information, or will this just be information that is 
gained along the way after the facility opens? 

Ms. Kingsbury. Well, the Kansas State University folks and the 
people who are putting that facility where they have selected to put 
it in the Department of Homeland Security will have to develop a 
design for the building, they will have to develop operating proto- 
cols, they will have to develop all of the things about how you 
would contain an outbreak if it did get out, and so forth. And those 
are the things that aren’t developed yet but hopefully would be de- 
veloped before any of that virus actually enters the building. 

Mr. Burgess. “Hopefully” may be a good word there as well. 

Dr. Atlas, do you have anything to add to that. 

Mr. Atlas. I think that one can design and operate a BSL4 agri- 
cultural facility safely. As to the exact location, the risks, I will 
leave that to the DHS and the community. But clearly the Kansas 
community wanted that facility there for that, in that location. It 
was not a matter of their saying, the Federal Government is put- 
ting something where we don’t want it. 

It was also clear that Plum Island either needed massive renova- 
tion or the facility needed to be relocated to a location where the 
scientific community would join in the critical research that is 
needed as was pointed out not only on foot and mouth disease but 
on many of the other agriculturally relevant agents that would be 
worked on there. 

So something had to be done to provide an adequate facility, and 
my contention is that you can build an adequate facility and locate 
it in an appropriate place. 

Mr. Burgess. An observation from Galveston a year ago of 
course Hurricane Ike ravaged the island as even today had some 
difficulty recovering but a brand new biodefense laboratory that at 
that point was not occupied but certainly came through what I 
would regard as a very serious stress test came through with pret- 
ty much flying colors. These labs are expensive to build. They are 
expensive to maintain. Is the funding level for both the building 
and the maintenance, are those funding levels adequate? Is that 
something that is receiving the appropriate amount of scrutiny and 
the appropriate amount of monitoring? 

Ms. Kingsbury. We didn’t directly look at what the funding level 
would be. There is an initial funding being discussed in current ap- 
propriations discussion, but what the entire facility will end up 
costing I think I would argue we don’t know yet. 

Mr. Burgess. What about the maintenance dollars? 

Ms. Kingsbury. We are very worried about the maintenance 
issue. The outbreak of foot and mouth disease in Great Britain was 
directly tieable to a maintenance issue in a relatively older facility. 
So as these facilities age, it will be very important to continue to 
pay attention to how much maintenance is going to be necessary 
and to provide the support for doing that. 



56 


Mr. Burgess. And the fact that that has to go through our an- 
nual appropriations process makes for some additional uncertainty. 

Ms. Kingsbury. In a time of very high budget constraints. 

Mr. Burgess. Sure. And again, Mr. Chairman, I think that is 
something this committee needs to pay particular attention to as 
we go through the next several years because as we have seen from 
our appropriators before, and I understand the difference between 
an authorizer and an appropriator. If you go up to the NIH, all the 
buildings were named for an appropriator, there is none named for 
an authorizer. I do understand the difference between an author- 
izer and appropriator, but it is certainly our job to keep up the 
oversight on that and when, as correctly Dr. Kingsbury pointed out, 
as those budgetary dollars are squeezed, we need to make certain 
that areas where legitimate functions of government are not com- 
promised. 

I will yield back the balance of my time. Thank you. 

Mr. Stupak. Thank you, Mr. Burgess. 

A couple of questions if I may. On page 32 you have table Num- 
ber 10 which shows the 12 Federal agencies that have the BSL3 
and BSL4 labs, but none of them outside their own agency know 
how many labs that really exist BSL3 or BSL4, correct? 

Ms. Kingsbury. That is correct. 

Mr. Stupak. You indicated in your testimony, how many of these 
12 agencies, I think people would be surprised even the Depart- 
ment of the Interior has these labs, how many of them have per- 
sonnel reliability measurements or protections of the 12 agencies? 
The Department of Defense you said, does anybody else? 

Ms. Kingsbury. We don’t think so. Do we? 

Mr. Sharma. Department of Energy. 

Mr. Stupak. Because of nuclear labs? 

Mr. Sharma. Within the last year they have begun to implement 
a personnel reliability program. 

Mr. Stupak. Just last year? 

Mr. Sharma. Yes. 

Mr. Stupak. So of the 12 agencies, the only robust one would be 
Department of Defense, Energy is starting, so we have 10 more 
without any kind of measurement. OK. 

Dr. Atlas, do you think academic and private institutions, do you 
think they should be registered labs level 4 and level 3? Do you 
think they should be registered with the government? 

Mr. Atlas. And I think the question is what comes with the reg- 
istration? If you just mean someone should send you a note that 
says we have a laboratory and it doesn’t bring anything else about, 
I don’t see much value. But there is also very little burden, so you 
are not going to get resistance to that. I think the Census, if you 
are going to register the labs you ought to be asking additional 
questions, and that is where the devil will be in the details about 
what it means to register and potentially be accredited at the end 
of the day. So I do see a value in a system that ensures increased 
biosafety, that reassures this committee and the public at large 
that what is going on in the laboratories is being appropriately 
done. 

Mr. Stupak. We don’t know what is going on in laboratories un- 
less they tell us, right? And if you are one of these select agents. 



57 


you are level 3 or you are level 4, so why would there he a reluc- 
tance to register with the government the labs? 

Mr. Atlas. I think first of all for the select agents, they are reg- 
istered. Everybody has to go through a clearance process. The gov- 
ernment knows exactly where those laboratories are and every- 
thing that is going on in those laboratories. If you talk about lab- 
oratories which might be isolating a new and emerging infectious 
disease organism, there are questions about how quickly and who 
you would tell and what you are doing particularly if you in the 
private sector. 

Mr. Stupak. Let’s say I am at a level 3 lab and I am not doing 
a non-select agency. Shouldn’t I still register with the government? 
One of the questions that has been going around here this morning 
is how many labs do we need. If we have 2,600 level 3 labs do we 
need 2,600? 

Mr. Atlas. I think it would go back to the question how many 
of these are coming from government funding? That is how much 
is the government investing versus someone sees an opportunity to 
develop a vaccine, is willing to invest in that vaccine or therapeutic 
drug development of which we have a real problem getting people 
to invest, but if companies see that and they build a laboratory to 
safely perform the work to develop a new vaccine against influenza 
virus, they ought to be able to do that I would argue, that that is 
part of the entrepreneurship of this country. Now should they have 
to do it safely? Absolutely. 

Mr. Stupak. Sure, but one of the criticisms has been we have 
thrown a lot of money at this issue since 2002. If there is a lot of 
BSL3 labs out there that could do the work, why would the govern- 
ment build more BSL3 labs because we don’t know if they are 
going to exist if we are not registered. I guess that is the part I 
am trying to get at. 

Mr. Atlas. I am not convinced that the government is spending 
a lot on building new laboratories. That was not as I saw it part 
of the GAO report was actually the dollars going into the labs. It 
was charts that showed an increase in the number of registered 
laboratories which may represent academic and private sector as 
well as the public sector. 

Mr. Stupak. And we don’t know, we don’t know how many there 
are. Even you point out in your testimony that the real expense is 
not just building but the maintaining because of the high level of 
sophistication you need to maintain a level 3 or level 4. 

Mr. Atlas. I think going back to the earlier question, that is 
where the ASM would also register our concern, is that we have 
to be vigilant about ensuring maintenance. 

Mr. Stupak. You make a number of recommendations about 
seven I heard here today and in the letter you sent in 2007 you 
had a number of them, and a lot of them probably would not re- 
quire Federal rules or laws such as increased training or reporting 
of incidents but has ASM membership, have you taken it upon 
yourself to do this without government regulation or government 
lead here and reporting incidents and doing training, you men- 
tioned training? Why doesn’t the organization do it instead of hav- 
ing government mandates? 



58 


Mr. Atlas. I think we look to the CDC and NIH to impact, take 
the leadership role in guiding the community in this regard. They 
are the primary authors along with USDA of the BMBL, and the 
ASM is seeking increased input into that process. But in terms of 
developing a responsible culture of reporting incidents, that I think 
needs to he within a government function. 

Mr. Stupak. I am just a little surprised. You are a scientist. I 
would think you would want to take the lead here in the develop- 
ment without government intervention or telling you how do it. 

Mr. Atlas. Where ASM comes from would he working with the 
government to in fact see that a system is implemented, not trying 
to undermine or circumvent what properly would he a role of public 
health. 

Mr. Stupak. Mr. Walden. 

Mr. Walden. Thank you, Mr. Chairman. Dr. Atlas, I sure appre- 
ciate your testimony and comments today. I especially when you 
said that you wouldn’t necessarily want the government deciding 
somebody couldn’t open the lab to go figure out the new and latest 
vaccine, I don’t want a government complete takeover of this whole 
process. What I want is to make sure those labs are safe and se- 
cure. And I think it makes sense that we kind of know what is out 
there, where they are, and I appreciate your testimony too and you 
talk about just sending in a note saying I am a lab and I am here 
doesn’t really accomplish the goals of safety and security. And so 
I appreciate what you have had to say today. 

You also had some really I thought good recommendations that 
you shared with us and I understand also shared with the Trans- 
Federal Task Force and the Executive Working Group. 

How were those recommendations received by those two organi- 
zations? 

Mr. Atlas. Well, we are waiting to see the report which we have 
not seen. They certainly had broad input not only from ASM but 
many other organizations shared viewpoints with both of those 
groups. They held public hearings. We attended those. There was 
broad input, and now we, like you, wait for the outcomes of that. 

Mr. Walden. And I appreciate that and we look forward to their 
response. My understanding is there are 242 entities doing this 
type of research that are registered, which then among those enti- 
ties constitute the 1,362 laboratories. So in a given university set- 
ting we can be sending Federal tax dollars in to do this research 
toward HlNl vaccine or toward anthrax vaccine or whatever we 
have decided as priorities, that goes into those 242 entities and 
within wherever they do their research they are multiple lab, 
right? 

Mr. Atlas. Yes. And how they decide to define a lab which may 
be that the animal facility may be one laboratory and then the 
room where you actually do research outside of the animals could 
be a second lab. One of the issues pointed out in the GAO report 
is that we do not have a standard definition for what constitutes 
a laboratory. We do have a definition of what an entity is that has 
to report that they have a select agent, but it has to be a contig- 
uous property. 

Mr. Walden. So let me switch gears for a second. If you were 
the National Security Council and you were advising the President, 



59 


who would you pick as the lead agency to oversee this national lab 
network? 

Mr. Atlas. I would see it from a safety perspective and a public 
health perspective and in turn to HHS, so the ASM as consistently 
sought the leadership of HHS and USDA and not supported in 
prior testimony a DHS oversight of that because we have seen it 
as a broad public health issue which then does combat pathogens 
which potentially are misused, but we are looking at the broad 
emergence of infectious diseases. 

Mr. Stupak. And that would also bring in CDC and their experts 
into that process. 

Mr. Atlas. Certainly CDS, NIH within the HHS context is there. 
Now ASM did support within the oversight system the involvement 
of the Department of Justice and the FBI clearance process for who 
could enter select agent labs, it wasn’t just saying put public health 
in charge where there are security concerns, but it did say if at the 
end of the day we are really concerned with protecting public 
health and animal health then the agencies that have experience 
in those areas ought to be the lead agencies. 

Mr. Walden. Dr. Kingsbury said there are long-term mainte- 
nance issues and they are quite concerned about them. 

Can you, representing those working in these labs, can you talk 
to us briefly, I know I have a minute left, in terms of those mainte- 
nance issues that are out there? 

Mr. Atlas. What we what we saw in the foot and mouth incident 
in England does raise the issue of maintenance, and certainly what 
we see in the academic community is you get the money up front 
for something and they will let the facilities run down, you never 
see them in any university I have been associated with, to have an 
adequate maintenance budget. So you keep deferring your mainte- 
nance. And in these facilities you can’t afford to do that. There 
really does need to be adequacy and oversight of maintenance. 

Mr. Walden. Thank you. I appreciate your testimony, both of 
you, today. Thank you, Mr. Chairman. 

Mr. Stupak. Mr. Gingrey, questions? 

Mr. Gingrey. No, Mr. Chairman. 

Mr. Stupak. Mr. Burgess, any follow-up? 

Mr. Burgess. Yes, Mr. Chairman, if I could just ask a general 
question. I guess Dr. Kingsbury, but Dr. Atlas, please feel free to 
weigh in as well. With regards to Plum Island, do we have a ball- 
park estimate as to what it would cost to do those upgrades that 
you alluded to that might be quite costly? 

Dr. Kingsbury. First of all, we would have to recognize that 
Plum Island has done already spent a lot of money upgrading their 
current facility. And when they made an application, if you will, to 
be considered in this recent decision process, they identified an- 
other part of their island where they could build the kind of facility 
that would need to be built to do the broader range of research. 
That is relatively costly compared to exactly the same building on 
the mainland because all the materials have to be shipped onto the 
island. So the DHS has always made that point as one of the rea- 
sons that they don’t find the Plum Island solution attractive. 

But you could build almost the same kind of building there. It 
is just a matter of whether the additional cost is prohibitive. There 



60 


have been expressed concerns about recruiting scientists to work on 
an island. It is a fairly pleasant 45-niinute ferry trip to get there. 
We have done it. It hasn’t seemed to be a big deal with respect to 
recruiting enough scientists. That remains to be seen if we were 
going to try to do that. But we recognize in our report that Plum 
Island has already invested a great deal in upgrading their current 
facility and for a 50-year-old building, it is in pretty good shape. 

Mr. Burgess. So in a dollar-to-dollar comparison, Plum Island 
versus an inland facility the cost is about the same but there are 
logistic issues that would make the building easier? 

Ms. Kingsbury. It would cost a lot of money. 

Mr. Burgess. But there are also security issues that will cost 
money at an inland facility that are perhaps not calculated in this 
equation? 

Ms. Kingsbury. That is correct, and DHS did not take that cost 
and those designs into account in making their decision. 

Mr. Burgess. Just going back to Mr. Walden’s point for a mo- 
ment about the HHS ultimate being the one who has the super- 
visory role, does there need to be an entity that oversees HHS on 
that because of the security concerns that exist that Mr. Walden 
was bringing up? I hesitate to use the word “czar,” but does there 
need to be a bio czar that is looking at this from more of a security 
standpoint? 

Mr. Walden. No more czars. 

Ms. Kingsbury. We focused most of our work on the biosafety 
side of these issues, not the biosecurity side. Some of our colleagues 
testified this morning on a physical security examination that they 
did of several of the BSL4 laboratories. The problem there is what 
is the actual threat and what is the experience that has happened 
over the past years of anybody breaking into a lab, and we are not 
aware of any incidents. That would suggest that physical security 
upgrades may or may not be needed. 

Mr. Burgess. On visiting the new lab in Galveston, I was im- 
pressed with the security. Always of course you do have to ask 
yourself what is the threat from an internal disruption or an 
Earth, someone who is working in the facility that decides to take 
a different approach to their employment. So what do we have 
available to help us with that? 

Ms. Kingsbury. Well, that is what a personnel reliability pro- 
gram would help with, but again even in that case there has been 
only one alleged case of an insider doing illegal things in the way 
that we all worry about. And so I think to study it and to think 
about how you are going to invest the taxpayers’ money, looking at 
the question from a somewhat broader context really is important, 
including how much of this research capacity do we need? We have 
built a lot of it as we have been talking about through this whole 
hearing there is a lot of young scientists out there getting very in- 
terested in these kinds of jobs. What happens if the funding for 
supporting that research dries up? Where are those scientists going 
to go with the skills that could make them insider threats if they 
were to get upset? 

So those are the kinds of issues that we think need to be studied 
in evaluating the national need here in comparison to other na- 
tional needs. 



61 


Mr. Burgess. Thank you. Thank you, Dr. Kingsbury. 

Mr. Chairman, I will yield back the balance of my time. 

Mr. Stupak. Thank you. Let me just ask a question here. Mr. 
Burgess and Mr. Gingrey brought up Plum Island. Both you and 
Dr. Sharma did the report, the GAO report on moving the foot and 
mouth disease off Plum Island to the mainland, right? 

Ms. Kingsbury. That is correct. 

Mr. Stupak. And if I remember correctly GAO did not conclude 
that the DHS study showed that foot and mouth disease can be 
done safely on the mainland? 

Ms. Kingsbury. That is correct. I am not going to take a case. 
Dr. Atlas’s belief that it could be done, but the evidence that we 
were given in the environmental impact statements, and so forth, 
do not demonstrate that point. 

Mr. Stupak. Very good. Any other questions? 

Mr. Burgess. Mr. Chairman, I would just ask unanimous con- 
sent that my opening statement can be inserted in the record. 

Mr. Stupak. We have done it earlier but fine. It will be entered. 

I want to thank the witnesses for their testimony. 

I want to be sure that GAO continues its oversight of the domes- 
tic and international lab proliferation. Dr. Kingsbury, your team 
has done good work, and I would ask that the GAO review the two 
reports which will hopefully be out in the next few weeks. Around 
here they always say a few weeks always means a few months, the 
one being Trans-Federal Task Force for Optimizing Biosafety and 
Biocontainment Oversight and the Executive Order Working Group 
on Strengthening the Biosecurity of the United States. This sub- 
committee would be interested in the proposals set forth in these 
two reports. We are asking that GAO assess any recommendations 
set forth in those reports and report back to us with your assess- 
ment. Will you do that for us? 

Ms. Kingsbury. Yes, sir. 

Mr. Stupak. Thank you, and that concludes our hearing. Mem- 
bers will have 

Mr. Walden. Can I ask while we are together here just two 
questions? One we had asked you and Chairman Waxman about 
the opportunity to do an oversight hearing and invite up the auto 
czar from the White House. We haven’t gotten a response to that 
letter from the end of June. 

Mr. Stupak. There have been a number of conversations going 
back and forth. I think the 28th is the end of the program, and 
speaking with some of the interest groups they said wait until we 
get the program done and we will see what went wrong and what 
went right with it. So there is still some interest in doing one. Yes. 

Mr. Walden. And the other issue involves insurance. I know 
that you and Mr. Waxman sent a letter to 52 heads of insurance 
companies asking for their financial information. I am wondering 
if we are any closer in knowing when we might have a hearing in- 
volving that issue. 

Mr. Stupak. We are kicking around some calendar dates. As you 
know, the majority leader has just given us some dates back, if you 
will, some Fridays, there has been some discussions if we are here 
on Thursday can we do a Friday morning hearing to get some of 
them done. We would like to have some hearings, not just on the 



62 


insurance industry but also what is the effect on small businesses 
and the cost of health insurance. I look forward to spending the 
next month and doing some hearings on insurance. I know we all 
have an interest in that. 

Mr. Walden. So within the next 30 days we may have multiple 
hearings on these issues? 

Mr. Stupak. We would like to assess how does the information 
come in and where we are going with it. 

Mr. Walden. Will we be looking at other contributors to that 
cost equation other than just the executive comp on insurance com- 
panies? 

Mr. Stupak. What is the cost on small businesses, if you have 
some examples, we would be happy to hear it. I just received one 
yesterday, about 30 percent increase for a small business. 

Mr. Walden. I was a small business owner for 22 years. I never 
throw the dart high enough on the budget planning board. 

Mr. Stupak. Is the 33 percent increase going into health care or 
is it going into other objects? That is what we want to know. 

Mr. Walden. Thank you very much. 

Mr. Stupak. Thank you. 

Mr. Burgess. Mr. Chairman, along that same line, if I could ask 
you or the ranking member, has that information that was gath- 
ered from those companies, has that been, has the majority staff 
shared that with the minority staff? 

Mr. Stupak. Everything we have, we haven’t even received ev- 
erything from every request we have made but the information wee 
received, minority class — staff — and they are class, has had access 
to it, and then it will continue, continue to have access to it. 

OK, committee will provide and members have 10 days to submit 
additional questions for the record. So if there are any more ques- 
tions we will get them to the appropriate party. That concludes our 
hearing. The meeting of the subcommittee is adjourned. 

[Whereupon, at 12:30 p.m., the subcommittee was adjourned.] 


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